PMA P000007S025
- Device
- EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2011-07-27
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR ATEX BIAS CLOTH.
Current openFDA PMA Record
- Device
- EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S025
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2011-07-27
- Decision code
- APPR
- Date received
- 2010-11-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR ATEX BIAS CLOTH.