PMA P870077S050
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE
- 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 DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S050
- 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
- Approval order statement
- APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.