CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP
FDA premarket approval P870077/S019 · decided 2005-05-20
Approval details
- PMA number
- P870077
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2005-04-28
- Decision date
- 2005-05-20
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
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