EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P
FDA premarket approval P000007/S010 · decided 2005-12-06
Approval details
- PMA number
- P000007
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2005-11-14
- Decision date
- 2005-12-06
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
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