{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:amplatzer-septal-occluder", "owner": "cardio", "kind": "product", "slug": "amplatzer-septal-occluder", "name": "Amplatzer Septal Occluder", "aliases": [ "Amplatzer ASO", "ASO" ], "atlases": [ "cardio" ], "summary_plain": "A device from Abbott that closes a hole between the two upper heart chambers (an atrial septal defect) through a catheter. NHLBI lists catheter repair and surgery as ways to close such a hole. The US FDA approved it in 2001 for atrial septal defects of the secundum type with echocardiographic evidence of the defect and clinical evidence of extra work for the right lower chamber (a left-to-right shunt of 1.5 to 1 or an enlarged right ventricle), and for closing the opening left after a fenestrated Fontan procedure. The FDA approval does not state an age range.", "summary_technical": "Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System, FDA product code MLV, PMA P000039, approved 2001-12-05. The approval order lists secundum atrial septal defect closure for patients with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload, and closure of the fenestration in patients who had a fenestrated Fontan procedure. NHLBI lists catheter procedures among the ways to repair a simple defect of this kind when it does not heal by itself. No trial results are recorded here.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "cardio": { "system": [ "heart" ], "condition-area": [ "valvular-and-congenital-disease" ] } }, "payload": { "subtype": "device", "model_or_formulation": "Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System", "version": "The record read is the original 2001 approval. Later supplements are not read here.", "intended_use_snapshots": [ "cardio:openfda-pma-p000039-2026-10-14" ] }, "content_digest": "ffa15e5551a7adcbad746bfb55ba67ddb37c9e2753bbd7bd6f95f32e3ca9806e", "review": { "content_digest": "ffa15e5551a7adcbad746bfb55ba67ddb37c9e2753bbd7bd6f95f32e3ca9806e", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-amplatzer-approved-scope", "owner": "cardio", "subject_entity_id": "cardio:amplatzer-septal-occluder", "category": "descriptive", "statement": "The Amplatzer Septal Occluder is FDA-approved for closing atrial septal defects in the secundum position through a catheter, in patients with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5 to 1 or right ventricular enlargement). The approval order also covers closing the fenestration after a fenestrated Fontan procedure. This states what the device is approved for. It is not a finding about how well the device works or how safe it is.", "context": { "id": "cardio:ctx-fda-p000039-secundum-asd", "label": "United States PMA approval P000039: Amplatzer Septal Occluder for secundum atrial septal defect", "recipient": "unknown", "population": "Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.", "care_setting": "Not stated in the FDA record", "geography": "United States (decision by the US Food and Drug Administration)", "life_stage_note": "Not stated in the FDA record", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [ "Atrial septal defect in the secundum position, with echocardiographic evidence", "Clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement)", "Or: a past fenestrated Fontan procedure that now needs the fenestration closed" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Describes the approval scope only. The order cited gives no age range, no trial results and no comparison with surgery; the summary of safety and effectiveness was not read. The link to adult congenital heart disease is the atlas's filing of the record: the approval does not say the patients are adults, and the NHLBI pages describe atrial septal defects as defects present at birth.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].ao_statement", "applicability_note": "The approval order statement: the approved indications.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "Date of the approval.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Atrial septal defect section", "applicability_note": "NHLBI describes what an atrial septal defect is.", "snapshot": { "id": "cardio:nhlbi-congenital-heart-defects-types-2026-10-14", "retrieved_at": "2026-10-14T18:22:37Z", "content_hash": "9d927334f1b5cfb2fa5e6b3c8eddb6bad4bf0d633b0b7ff03f4281ef357a6588", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:nhlbi-congenital-heart-defects-types", "source_type": "webpage", "title": "Congenital Heart Defects: Types (NHLBI)", "canonical_url": "https://www.nhlbi.nih.gov/health/congenital-heart-defects/types", "identifiers": [], "publication_date": null, "publisher": "National Heart, Lung, and Blood Institute (NIH)", "edition": "Page fetched 2026-10-14. The page says it was last updated on March 24, 2022.", "reuse_basis": "NHLBI is part of the U.S. National Institutes of Health. The pages carry third-party material, such as animations credited to Nucleus Medical Media, that this atlas does not use. NIH's own web policy page returned HTTP 403 to a script on 2026-10-14 (cj-nih-web-policies.html and cj-nih-web-policies-alt.html), and the NHLBI privacy and accessibility page (cj-nhlbi-privacy-accessibility.html) says nothing about reuse, so this atlas has not read NHLBI's own reuse terms. Public text is cite_only until they are read; the integration owner can change it to quote. Hash only; the page is not committed.", "public_text": "cite_only" } }, { "evidence_role": "context", "locator": "Procedures section", "applicability_note": "NHLBI names cardiac catheterization as a way to repair a simple defect such as an atrial septal defect.", "snapshot": { "id": "cardio:nhlbi-congenital-heart-defects-treatment-2026-10-14", "retrieved_at": "2026-10-14T18:22:38Z", "content_hash": "2461de12d2112bac2ca9dc9b277263fbf6804c9ee8185d3d7d49a21deef6a8ca", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:nhlbi-congenital-heart-defects-treatment", "source_type": "webpage", "title": "Congenital Heart Defects: Treatment (NHLBI)", "canonical_url": "https://www.nhlbi.nih.gov/health/congenital-heart-defects/treatment", "identifiers": [], "publication_date": null, "publisher": "National Heart, Lung, and Blood Institute (NIH)", "edition": "Page fetched 2026-10-14. The page says it was last updated on March 24, 2022.", "reuse_basis": "NHLBI is part of the U.S. National Institutes of Health. The pages carry third-party material, such as animations credited to Nucleus Medical Media, that this atlas does not use. NIH's own web policy page returned HTTP 403 to a script on 2026-10-14 (cj-nih-web-policies.html and cj-nih-web-policies-alt.html), and the NHLBI privacy and accessibility page (cj-nhlbi-privacy-accessibility.html) says nothing about reuse, so this atlas has not read NHLBI's own reuse terms. Public text is cite_only until they are read; the integration owner can change it to quote. Hash only; the page is not committed.", "public_text": "cite_only" } } ], "review": { "content_digest": "0a60755b40beffba2280f8147da6ccfc683c49daf004ac30ba1e625315d7ab55", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-amplatzer-approved-scope.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p000039-approval", "owner": "cardio", "subject_entity_id": "cardio:amplatzer-septal-occluder", "category": "regulatory", "statement": "On 2001-12-05 the US Food and Drug Administration approved the Amplatzer Septal Occluder (ASO) and the Amplatzer Exchange System under PMA P000039, product code MLV, applicant ABBOTT MEDICAL. The approval order states the occluder is indicated for occlusion of atrial septal defects in the secundum position, and also for patients who have had a fenestrated Fontan procedure and now need the fenestration closed. Patients indicated for atrial septal defect closure have echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement). The Exchange System is for removing an Amplatzer delivery sheath and exchanging it for one of equal or larger diameter.", "context": { "id": "cardio:ctx-fda-p000039-secundum-asd", "label": "United States PMA approval P000039: Amplatzer Septal Occluder for secundum atrial septal defect", "recipient": "unknown", "population": "Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.", "care_setting": "Not stated in the FDA record", "geography": "United States (decision by the US Food and Drug Administration)", "life_stage_note": "Not stated in the FDA record", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [ "Atrial septal defect in the secundum position, with echocardiographic evidence", "Clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement)", "Or: a past fenestrated Fontan procedure that now needs the fenestration closed" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The order gives no age range. Closing the opening in a heart is also done by surgery; this record does not compare the two.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].pma_number", "applicability_note": "The PMA number of this record.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].applicant", "applicability_note": "The applicant, as FDA writes the name.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].trade_name", "applicability_note": "The trade name FDA gives this record.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "ISO date of the decision.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_code", "applicability_note": "FDA decision code: APPR is an approval.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "FDA product code of this record.", "snapshot": { "id": "cardio:openfda-pma-p000039-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p000039", "source_type": "regulator", "title": "FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P000039&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P000039", "normalized_value": "P000039", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. 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This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } } ], "review": { "content_digest": "f71f90398b21441a5925a4f50fde0d1408d6fee7de860d4e6e24190720536596", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-p000039-approval.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-p000039", "product_id": "cardio:amplatzer-septal-occluder", "product_version": "Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System (original approval)", "indication": "Occlusion of atrial septal defects in the secundum position (with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload), and closure of the fenestration in patients who have had a fenestrated Fontan procedure. The Exchange System is for exchanging an Amplatzer delivery sheath.", "context_id": "cardio:ctx-fda-p000039-secundum-asd", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "approval", "recall_class": null, "submission_id": "P000039", "pathway": "pma", "product_code": "MLV", "device_class": "III", "decision_date": "2001-12-05", "valid_to": null, "claim_id": "cardio:claim-fda-p000039-approval" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "manufactured_by", "label": "Applicant on P000039 is ABBOTT MEDICAL; the sources read do not say who makes the device", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:abbott", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:openfda-pma-p000039-2026-10-14", "locator": "results[0].applicant" }, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "evaluated_for", "label": "FDA approval scope only: closing secundum atrial septal defects through a catheter, in patients with echocardiographic evidence of the defect and right ventricular volume overload (a shunt of 1.5 to 1 or an enlarged right ventricle); the approval states no age range and reports no trial results", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "cardio:adult-congenital-heart-disease", "other_entity_in_atlas": true, "claim_id": "cardio:claim-amplatzer-approved-scope", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "cardio:front-procedures-and-surgery", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [] }, "page_path": "products/amplatzer-septal-occluder/", "context_path": "api/v1/context/cardio--amplatzer-septal-occluder.md" }