EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM
FDA premarket approval P100041/S006 · decided 2012-03-20
Approval details
- PMA number
- P100041
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2012-01-26
- Decision date
- 2012-03-20
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR USE OF A PREVIOUSLY APPROVED ALTERNATE MATERIAL FOR THE FLUSH TUBE.
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510(k) clearances by this applicant
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