PMA P130009S062
- Device
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S062
- Product code
- NPT
- Decision date
- 2016-08-19
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for various changes to the post-approval study protocol for the continued follow-up of the IDE Nested Registry #3.
Current openFDA PMA Record#
- Device
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S062
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2016-08-19
- Decision code
- APPR
- Date received
- 2016-07-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for various changes to the post-approval study protocol for the continued follow-up of the IDE Nested Registry #3.