PMA P110021S018
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S018
- Product code
- NPT
- Decision date
- 2013-07-03
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- IMPLEMENTATION OF A POSITIONING FIXTURE AS AN ALTERNATIVE MANUFACTURING AID USED WHILE PLACING TEMPORARY STITCHES ON TISSUE LEAFLETS.
Current openFDA PMA Record#
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S018
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-07-03
- Decision code
- OK30
- Date received
- 2013-06-06
- Supplement type
- 30-Day Notice
- Approval order statement
- IMPLEMENTATION OF A POSITIONING FIXTURE AS AN ALTERNATIVE MANUFACTURING AID USED WHILE PLACING TEMPORARY STITCHES ON TISSUE LEAFLETS.