PMA P100041S001
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S001
- Product code
- NPT
- Decision date
- 2012-01-31
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- APPROVAL FOR POST-APPROVAL STUDY PROTOCOL,
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S001
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2012-01-31
- Decision code
- APPR
- Date received
- 2011-12-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL FOR POST-APPROVAL STUDY PROTOCOL,