CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP
FDA premarket approval P870077/S018 · decided 2005-04-08
Approval details
- PMA number
- P870077
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2005-03-21
- Decision date
- 2005-04-08
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
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