PMA P870077S049
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S049
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF JAR TORQUE MACHINES.