Sapien 3 Transcatheter Heart Valve
FDA premarket approval P140031/S052 · decided 2017-09-28
Approval details
- PMA number
- P140031
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sapien 3 Transcatheter Heart Valve
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2017-08-23
- Decision date
- 2017-09-28
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for updates to the labeling to include instructions for implantation using the subclavian and axillary access approaches.
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510(k) clearances by this applicant
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|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
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| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
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| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |