PMA P010041S046
- Device
- CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2013-12-19
- Generic name
- replacement Heart-valve
- Approval order statement
- ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S046
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2013-12-19
- Decision code
- OK30
- Date received
- 2013-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.