PMA P000007S033
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2012-09-19
- Generic name
- replacement Heart-valve
- Approval order statement
- MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S033
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-09-19
- Decision code
- OK30
- Date received
- 2012-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.