EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA premarket approval P140031/S002 · decided 2016-03-16
Approval details
- PMA number
- P140031
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2015-08-19
- Decision date
- 2016-03-16
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing site located at Edwards Lifesciences Pte., in Singapore, Singapore.
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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 |