SAPIEN XT TRANSCATHETER HEART VALVE
FDA premarket approval P130009/S032 · decided 2015-04-13
Approval details
- PMA number
- P130009
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SAPIEN XT TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2015-03-17
- Decision date
- 2015-04-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ALTERNATE SAMPLING PLAN FOR THE STENT COMPONENT.
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