PMA P870077S045
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2012-07-11
- Generic name
- replacement Heart-valve
- Approval order statement
- AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S045
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-07-11
- Decision code
- OK30
- Date received
- 2012-06-13
- Supplement type
- 30-Day Notice
- Approval order statement
- AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.