CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE
FDA premarket approval P860057/S014 · decided 2000-08-04
Approval details
- PMA number
- P860057
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2000-07-13
- Decision date
- 2000-08-04
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER USED IN THE MANUFACTURE OF THE HEART VALVE.
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