EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA premarket approval P140031/S008 · decided 2016-02-16
Approval details
- PMA number
- P140031
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2016-02-05
- Decision date
- 2016-02-16
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Implement an automated data analysis spreadsheet for use during the incoming inspection for the frame tubing.
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