EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA premarket approval P100041/S047 · decided 2014-02-12
Approval details
- PMA number
- P100041
- Supplement
- S047
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-01-15
- Decision date
- 2014-02-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING.
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