PMA P870077S043
- Device
- CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2012-04-13
- Generic name
- replacement Heart-valve
- Approval order statement
- NEW SUPPLIER FOR SELVEDGE YARN.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S043
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-04-13
- Decision code
- OK30
- Date received
- 2012-03-20
- Supplement type
- 30-Day Notice
- Approval order statement
- NEW SUPPLIER FOR SELVEDGE YARN.