PMA P870077S038
- Device
- CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2011-01-20
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S038
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2011-01-20
- Decision code
- OK30
- Date received
- 2010-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.