PMA P100041S006
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S006
- Product code
- NPT
- Decision date
- 2012-03-20
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- APPROVAL FOR USE OF A PREVIOUSLY APPROVED ALTERNATE MATERIAL FOR THE FLUSH TUBE.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S006
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2012-03-20
- Decision code
- APPR
- Date received
- 2012-01-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF A PREVIOUSLY APPROVED ALTERNATE MATERIAL FOR THE FLUSH TUBE.