PMA P100041S004
- Device
- Edwards Sapien Transcatheter Heart Valve
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S004
- Decision date
- 2012-01-18
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S004
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2012-01-18
- Decision code
- OK30
- Date received
- 2011-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL SUPPLIER OF BOVINE TISSUE.