SAPIEN 3 TRANSCATHETER HEART VALVE
FDA premarket approval P140031/S003 · decided 2016-01-26
Approval details
- PMA number
- P140031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SAPIEN 3 TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2015-10-07
- Decision date
- 2016-01-26
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR VARIOUS DESIGN AND MANUFACTURING CHANGES TO THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, INCLUDING CHANGE IN MATERIAL SPECIFICATION FOR THE POLYETHYLENE TEREPHTHALATE (PET) RIBBON, CHANGE IN SUTURE MATERIAL, AND REDUCTION IN THE NUMBER OF PERMANENT STITCHES.
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