PMA P100041S009
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S009
- Product code
- NPT
- Decision date
- 2012-05-09
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- ALTERNATE RECEIVING INSPECTION SITE.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S009
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2012-05-09
- Decision code
- OK30
- Date received
- 2012-04-23
- Supplement type
- 30-Day Notice
- Approval order statement
- ALTERNATE RECEIVING INSPECTION SITE.