CardioMEMS HF System

A small sensor that is placed in an artery of the lung to measure the pressure there and send the readings wirelessly. The US FDA approved it on 28 May 2014 for people with NYHA class III heart failure who have been in hospital for heart failure in the previous year. In the CHAMPION trial, people whose care was adjusted using these readings had fewer hospital admissions for heart failure over 6 months than people given standard care alone. Only patients were masked in that trial.

Also called CardioMEMS HF Pressure Measurement System

Product
In this atlas

Overview

Technical summary

Premarket approval P100045, product code MOM, device class 3. The approval order statement in the openFDA record lists the CM2000 implantable sensor and monitor with its delivery system, the patient electronics and the hospital electronics. The record lists ABBOTT MEDICAL as the applicant today and 90 later supplements; their content was not read. The registry names the CHAMPION device HF Pressure Measurement System, and the openFDA trade name is CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM; this page does not state that the trial device and the approved device are the same product version. The current openFDA registration listing names Abbott Medical as a manufacturing establishment for the P100045 devices; that listing is current and does not show who made the sensor in 2014.

Product details

Type: Device
Model or formulation: CardioMEMS HF System: implantable pulmonary artery sensor and monitor, delivery system, patient electronics and hospital electronics
Version: Not stated. The record lists many later supplements and the version under study in CHAMPION is not stated.

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context Adults with NYHA class III heart failure and a past heart-failure hospital admission, at 64 US centres (CHAMPION)

Recipient: Adult
Population: Patients with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure. The registry gives a minimum age of 18 years.
Care setting: Enrolled at 64 centres in the USA (abstract). The abstract does not say whether they were hospitals or outpatient clinics.
Geography: United States (abstract and registry).
Life stage: Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
Follow-up: At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).

Eligibility: 2 inclusion criteria; 1 exclusion criterion

Included: NYHA class III heart failure, irrespective of ejection fraction
Previous hospital admission for heart failure
Excluded: Exclusion criteria were not read; the abstract does not list them

Effect Interventional Certainty not assessed

In CHAMPION, people with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure were randomly assigned to management with a wireless implantable haemodynamic monitoring system (treatment group) or to a control group, for at least 6 months. In the treatment group, clinicians used daily pulmonary artery pressure readings in addition to standard care; the control group had standard care alone. Only patients were masked to their group. At 6 months there were 83 heart-failure-related hospitalisations in the treatment group (270 people) and 120 in the control group (280 people), a rate of 0.31 against 0.44 (hazard ratio 0.70, 95% CI 0.60 to 0.84). Over the whole follow-up, with a mean of 15 months, there were 153 such hospitalisations in the treatment group against 253 in the control group (hazard ratio 0.64, 95% CI 0.55 to 0.75). Eight patients had a device-related or system-related complication; freedom from these was 98.6% (95% CI 97.3 to 99.4) against a prespecified criterion of 80%, and freedom from pressure-sensor failure was 100% (99.3 to 100.0).

Source problem. A cited source is corrected. Check the sources before relying on this claim.
Applies to Adult
- Patients with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure. The registry gives a minimum age of 18 years.
- Enrolled at 64 centres in the USA (abstract). The abstract does not say whether they were hospitals or outpatient clinics.
- United States (abstract and registry).
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
Follow-up At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).
Certainty method
Not assessed

Limitations
One single-blind trial: only patients were masked, so clinicians were not. The comparison counts hospitalisations as events, not people. The abstract names CardioMEMS as the funder, and the device studied is the CardioMEMS system. PubMed links an erratum to the paper (Lancet 2012;379:412), and Crossref lists an erratum with DOI 10.1016/s0140-6736(12)60193-7 dated 2012-02-04. The erratum text could not be read, so it is unknown whether it changes any figure here. The numbers come from the PubMed abstract; the full text and registry results were not read. The abstract gives no result on deaths. No certainty rating was assessed.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (9)
1. Supports Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, FINDINGS, sentence 1
  
  How it applies
  Six-month hospitalisation counts, group sizes and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, FINDINGS, sentence 2
  
  How it applies
  Whole follow-up hospitalisation counts and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Supports Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, FINDINGS, sentence 3
  
  How it applies
  Device-related complications and sensor failures. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Background Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, METHODS, sentence 1
  
  How it applies
  Population and sites. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
5. Background Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, METHODS, sentence 2
  
  How it applies
  Randomization and the length of the comparison. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
6. Background Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, METHODS, sentence 3
  
  How it applies
  Only patients were masked. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
7. Background Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, METHODS, sentence 4
  
  How it applies
  What the treatment group did differently. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
8. Background Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
  
  Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read. · Published 2011-02-19 · DOI: 10.1016/S0140-6736(11)60101-3 · PMID: 21315441
  
  Locator
  Abstract, FUNDING, sentence 1
  
  How it applies
  Funder named in the abstract. Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:46Z
  
  Source effective date
  Not reported
  
  Source state
  Corrected
  
  Snapshot hash
  d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
9. Background Crossref record for the CHAMPION paper (10.1016/S0140-6736(11)60101-3)
  
  Dataset · Crossref · Edition Crossref REST API record fetched 2026-10-14. It lists one update to the paper, an erratum.
  
  Locator
  message.updated-by[0].DOI
  
  How it applies
  Crossref lists an erratum for this paper, by DOI.
  
  Retrieved
  2026-10-14T19:17:15Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  b76a0476b5ad9cf55365b1463d2ff356f63acaba583a8777e58afd3913eb899b
  
  Reuse basis
  The Crossref terms were not read, so the reuse basis is unverified. Only the hash of the response is kept and nothing from it is quoted in a record.

Context United States premarket approval P100045 for the CardioMEMS HF System

Recipient: Recipient not specified
Population: People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.
Care setting: Not stated in the FDA record beyond the indication wording.
Geography: United States (decision by the US Food and Drug Administration)
Life stage: Not stated in the openFDA record. The indication wording gives no age limits.
Gestational age: Not reported
Postnatal age: Not reported
Follow-up: Not applicable (regulatory decision)

Eligibility: 2 inclusion criteria; exclusion criteria not stated

Included: NYHA class III heart failure
Hospitalized for heart failure in the previous year
Excluded: None stated

Regulatory Evidence stage not applicable Certainty not assessed

The US Food and Drug Administration approved premarket approval application P100045 for the CardioMEMS HF Pressure Measurement System on 28 May 2014. The approval order statement in the openFDA record says the device is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in New York Heart Association class III heart failure patients who have been hospitalized for heart failure in the previous year, and that physicians use the hemodynamic data for heart failure management with the goal of reducing heart failure hospitalizations. The record lists FDA product code MOM and device class 3.
Applies to Recipient not specified
- People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.
- Not stated in the FDA record beyond the indication wording.
- United States (decision by the US Food and Drug Administration)
- Not stated in the openFDA record. The indication wording gives no age limits.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Certainty method
Not assessed

Limitations
The openFDA record is the original approval; the same response lists many later supplements, whose content was not read, so the indication may have changed. The record lists ABBOTT MEDICAL as the applicant today and does not say who held the application in 2014. The approval order statement is FDA's wording of the indication and is not a finding about how well the device works. openFDA's own disclaimer says not to rely on it for decisions about medical care.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (8)
1. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].pma_number
  
  How it applies
  The PMA number. The record with an empty supplement_number is the original approval.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
2. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].decision_date
  
  How it applies
  ISO decision date of the original approval.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
3. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].decision_code
  
  How it applies
  APPR is FDA's decision code for an approval.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
4. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].trade_name
  
  How it applies
  The trade name as the record writes it.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
5. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].ao_statement
  
  How it applies
  The approval order statement gives the indication.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
6. Supports openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].product_code
  
  How it applies
  FDA product code.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
7. Background openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].openfda.device_class
  
  How it applies
  Device class as the openFDA block writes it.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.
8. Background openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement_number (results[53]). · PMA: P100045
  
  Locator
  results[53].applicant
  
  How it applies
  The applicant as the record now lists it; it does not say who held the application in 2014.
  
  Retrieved
  2026-10-14T18:20:06Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-pma-p100045.json.

Authorization

Regulatory decision: CardioMEMS HF System

Applies to Recipient not specified

People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.
Not stated in the FDA record beyond the indication wording.
United States (decision by the US Food and Drug Administration)
Not stated in the openFDA record. The indication wording gives no age limits.
Gestational age Not reported
Postnatal age Not reported

Follow-up Not applicable (regulatory decision)

Authority: U.S. Food and Drug Administration
Decision: Approval, 2014-05-28
Pathway: PMA
Submission: P100045
Product code: MOM
Device class: Class III
Jurisdictions: United States; note: United States
Product version: CardioMEMS HF System, which the approval order statement lists as the CM2000 implantable sensor and monitor with its delivery system, patient electronics and hospital electronics
Indication: Wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA class III heart failure patients who have been hospitalized for heart failure in the previous year, to inform heart failure management with the goal of reducing hospitalizations (FDA approval order statement)

Basis: The US Food and Drug Administration approved premarket approval application P100045 for the CardioMEMS HF Pressure Measurement System on 28 May 2014. The approval order statement in the openFDA record says the device is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in New York Heart Association class III heart failure patients who have been hospitalized for heart failure in the previous year, and that physicians use the hemodynamic data for heart failure management with the goal of reducing heart failure hospitalizations. The record lists FDA product code MOM and device class 3.
Limitations. The openFDA record is the original approval; the same response lists many later supplements, whose content was not read, so the indication may have changed. The record lists ABBOTT MEDICAL as the applicant today and does not say who held the application in 2014. The approval order statement is FDA's wording of the indication and is not a finding about how well the device works. openFDA's own disclaimer says not to rely on it for decisions about medical care.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact CHAMPION: fewer heart-failure hospitalisations with pressure-guided management than with standard care: Heart failure (Evaluated for)
Applies to Adult
- Patients with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure. The registry gives a minimum age of 18 years.
- Enrolled at 64 centres in the USA (abstract). The abstract does not say whether they were hospitals or outpatient clinics.
- United States (abstract and registry).
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
Follow-up At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).
In CHAMPION, people with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure were randomly assigned to management with a wireless implantable haemodynamic monitoring system (treatment group) or to a control group, for at least 6 months. In the treatment group, clinicians used daily pulmonary artery pressure readings in addition to standard care; the control group had standard care alone. Only patients were masked to their group. At 6 months there were 83 heart-failure-related hospitalisations in the treatment group (270 people) and 120 in the control group (280 people), a rate of 0.31 against 0.44 (hazard ratio 0.70, 95% CI 0.60 to 0.84). Over the whole follow-up, with a mean of 15 months, there were 153 such hospitalisations in the treatment group against 253 in the control group (hazard ratio 0.64, 95% CI 0.55 to 0.75). Eight patients had a device-related or system-related complication; freedom from these was 98.6% (95% CI 97.3 to 99.4) against a prespecified criterion of 80%, and freedom from pressure-sensor failure was 100% (99.3 to 100.0).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. One single-blind trial: only patients were masked, so clinicians were not. The comparison counts hospitalisations as events, not people. The abstract names CardioMEMS as the funder, and the device studied is the CardioMEMS system. PubMed links an erratum to the paper (Lancet 2012;379:412), and Crossref lists an erratum with DOI 10.1016/s0140-6736(12)60193-7 dated 2012-02-04. The erratum text could not be read, so it is unknown whether it changes any figure here. The numbers come from the PubMed abstract; the full text and registry results were not read. The abstract gives no result on deaths. No certainty rating was assessed.

Record details

Record id: cardio:cardiomems-hf-system
Content hash: 4fcb92db75a316338ab6e2be8adceb12835810f585aa6bd1f34f7754954cc01a