Cardiovascular Atlas
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Regulatory decisions

Approvals, clearances, recalls and other decisions of a regulator on a product, with the pathway where the record names one.

29 events of 208. A year or a month is never shown as a day, and a year-only date sorts below the dated events of that year. Expected future events are on the calendar.

2024 1

  1. Approval TriClip

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P230007 · Where: United States

    Source: FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

2022 1

  1. Approval Tirzepatide (Mounjaro)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA215866 · Where: United States

    Sources: FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record); Drugs@FDA: approval date(s) and history for NDA 215866 (Mounjaro); Mounjaro drug label (openFDA record, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0)

2021 3

  1. Approval Inclisiran (Leqvio)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA214012 · Where: United States

    Sources: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record); Drugs@FDA overview page for NDA214012; LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)

  2. Approval Finerenone (Kerendia)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA215341 · Where: United States

    Sources: FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record); Drugs@FDA: approval date(s) and history for NDA 215341 (Kerendia)

  3. Approval Semaglutide injection for weight management (Wegovy)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA215256 · Where: United States

    Sources: FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record); Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy); WEGOVY drug label (openFDA record, set id f5e548d0-cc79-4c34-a3f5-e20a5b8b6564)

2019 4

  1. Supplemental approval CoreValve and Evolut transcatheter valves

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P130021/S058 · Where: United States

    Sources: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record); FDA approval order for PMA supplement P130021/S058 (CoreValve Evolut R and Evolut PRO, low-risk indication)

  2. Supplemental approval SAPIEN 3 transcatheter heart valve

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P140031/S085 · Where: United States

    Sources: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record); FDA approval order for PMA supplement P140031/S085 (SAPIEN 3 and SAPIEN 3 Ultra, low-risk indication)

  3. Approval HeartStart OnSite and Home defibrillators

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P160029 · Where: United States

    Sources: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval); FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators); FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

  4. Supplemental approval MitraClip

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P100009/S028 · Where: United States

    Sources: FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record); FDA approval order for PMA supplement P100009/S028 (MitraClip, secondary mitral regurgitation)

2018 1

  1. Granted Irregular Rhythm Notification Feature (Apple)

    Authority: U.S. Food and Drug Administration · Pathway: De Novo · Submission: DEN180042 · Where: United States

    Sources: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record); FDA Device Classification Under Section 513(f)(2) (De Novo): DEN180042, Irregular Rhythm Notification Feature

2017 3

  1. Approval Semaglutide injection for diabetes (Ozempic)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA209637 · Where: United States

    Sources: FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record); Drugs@FDA: approval date(s) and history for NDA 209637 (Ozempic); Ozempic drug label (openFDA record, set id 42bdd912-2393-44c4-b7e0-47672ca28991)

  2. Supplemental approval Melody transcatheter pulmonary valve

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P140017/S005 · Where: United States

    Sources: FDA premarket approval record P140017/S005: Melody Transcatheter Pulmonary Valve (PMA supplement S005, surgical bioprosthetic pulmonary valve) (openFDA record); FDA approval order for PMA supplement P140017/S005 (Melody valve, surgical bioprosthetic pulmonary valve)

  3. Clearance Elecsys Troponin T Gen 5 STAT assay

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K162895 · Where: United States

    Sources: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record); FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

2015 5

  1. Approval Evolocumab (Repatha)

    Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA125522 · Where: United States

    Sources: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record); Drugs@FDA overview page for BLA125522; REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)

  2. Approval Sacubitril/valsartan (Entresto)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA207620 · Where: United States

    Sources: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets); Drugs@FDA overview page for NDA 207620 (ENTRESTO)

  3. Approval SAPIEN 3 transcatheter heart valve

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P140031 · Where: United States

    Sources: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record); FDA summary of safety and effectiveness data for PMA P140031 (SAPIEN 3)

  4. Approval WATCHMAN left atrial appendage closure device

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P130013 · Where: United States

    Source: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

  5. Approval Melody transcatheter pulmonary valve

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P140017 · Where: United States

    Sources: FDA premarket approval record P140017: Melody Transcatheter Pulmonary Valve and Ensemble delivery system (original PMA approval) (openFDA record); FDA summary of safety and effectiveness data for PMA P140017 (Melody valve)

2014 4

  1. Approval Empagliflozin (Jardiance)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA204629 · Where: United States

    Sources: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets); Drugs@FDA overview page for NDA 204629 (JARDIANCE)

  2. Approval CardioMEMS HF System

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P100045 · Where: United States

    Source: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System

  3. Approval CoreValve and Evolut transcatheter valves

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P130021 · Where: United States

    Sources: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record); FDA summary of safety and effectiveness data for PMA P130021 (CoreValve)

  4. Approval Dapagliflozin (Farxiga)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA202293 · Where: United States

    Sources: openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets); Drugs@FDA overview page for NDA 202293 (FARXIGA)

2013 1

  1. Approval MitraClip

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P100009 · Where: United States

    Source: FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)

2012 2

  1. Approval Apixaban (Eliquis)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA202155 · Where: United States

    Sources: FDA drug application NDA202155 (openFDA Drugs@FDA record); FDA approval letter for NDA NDA202155

  2. Approval Subcutaneous ICD (S-ICD) system

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P110042 · Where: United States

    Sources: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval); FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012); FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system)

2011 1

  1. Approval Rivaroxaban (Xarelto)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA202439 · Where: United States

    Sources: FDA drug application NDA202439 (openFDA Drugs@FDA record); FDA approval letter for NDA NDA202439; FDA drug application NDA022406 (openFDA Drugs@FDA record); FDA approval letter for NDA NDA022406

2010 1

  1. Approval Dabigatran (Pradaxa)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA022512 · Where: United States

    Sources: FDA drug application NDA022512 (openFDA Drugs@FDA record); FDA approval letter for NDA NDA022512

2001 1

  1. Approval Amplatzer Septal Occluder

    Authority: U.S. Food and Drug Administration · Pathway: PMA · Submission: P000039 · Where: United States

    Source: FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

2000 1

  1. Clearance Omron HEM-907 blood pressure monitor

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K001848 · Where: United States

    Source: FDA 510(k) premarket notification K001848: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (openFDA record)