EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
FDA premarket approval P100041 · decided 2011-11-02
Approval details
- PMA number
- P100041
- Trade name
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2010-11-01
- Decision date
- 2011-11-02
- Days to decision
- 366 days
- Decision code
- APWD
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23MM AND 26MM AND ACCESSORIES. THIS DEVICE IS INDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC NATIVE AORTIC VALVE STENOSIS WHO HAVE BEEN DETERMINED BY A CARDIAC SURGEON TO BE INOPERABLE FOR OPEN AORTIC VALVE REPLACEMENT AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| 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 |