PMA P870077S036
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2010-02-24
- Generic name
- replacement Heart-valve
- Approval order statement
- ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S036
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2010-02-24
- Decision code
- OK30
- Date received
- 2010-01-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.