PMA P010041S005
Current openFDA PMA Record
- Device
- CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S005
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-01-19
- Decision code
- OK30
- Date received
- 2004-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.