PMA P010041S004
- Device
- CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2004-12-29
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S004
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2004-12-29
- Decision code
- APPR
- Date received
- 2004-09-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.