PMA P100041S012
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S012
- Product code
- NPT
- Decision date
- 2012-07-11
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- 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
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S012
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- 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.