PMA P870077S059
- Device
- DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2014-03-14
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
Current openFDA PMA Record
- Device
- DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S059
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-03-14
- Decision code
- OK30
- Date received
- 2014-02-25
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.