PMA P010041S037
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S037
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-12-10
- Decision code
- OK30
- Date received
- 2012-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.