CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE
FDA premarket approval P860057/S010 · decided 1999-04-13
Approval details
- PMA number
- P860057
- Supplement
- S010
- 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
- 1999-03-26
- Decision date
- 1999-04-13
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environmental prior to stent assembly.
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