PMA P870077S058
- Device
- DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2014-01-23
- 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 BIOSTHESIS WITH EXTENDED RING
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S058
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-01-23
- Decision code
- OK30
- Date received
- 2013-12-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.