PMA P100041S052
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S052
- Product code
- NPT
- Decision date
- 2014-05-01
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- ADDITION OF AN ALTERNATE TISSUE SUPPLIER.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S052
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-05-01
- Decision code
- OK30
- Date received
- 2014-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE TISSUE SUPPLIER.