PMA P000007S026
- Device
- EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2010-12-22
- Generic name
- replacement Heart-valve
- Approval order statement
- USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
Current openFDA PMA Record
- Device
- EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S026
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2010-12-22
- Decision code
- OK30
- Date received
- 2010-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.