PMA P010041S039
- Device
- CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2013-02-28
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S039
- 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.