SAPIEN TRANSCATHETER HEART VALVE (THV)
FDA premarket approval P100041/S059 · decided 2014-10-20
Approval details
- PMA number
- P100041
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SAPIEN TRANSCATHETER HEART VALVE (THV)
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-09-22
- Decision date
- 2014-10-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.
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510(k) clearances by this applicant
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|---|---|---|
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| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
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