PMA P110021S016
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S016
- Product code
- NPT
- Decision date
- 2013-06-25
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S016
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-06-25
- Decision code
- OK30
- Date received
- 2013-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.