PMA P000007S037
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S037
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2013-02-28
- Decision code
- APPR
- Date received
- 2012-11-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.