EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA premarket approval P100041/S008 · decided 2012-08-20
Approval details
- PMA number
- P100041
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2012-03-08
- Decision date
- 2012-08-20
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.
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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 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |