PMA P100041S064
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S064
- Product code
- NPT
- Decision date
- 2015-02-27
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- EXTEND A WATER LOOP IN THE DRAPER, UTAH FACILITY.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S064
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2015-02-27
- Decision code
- OK30
- Date received
- 2015-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXTEND A WATER LOOP IN THE DRAPER, UTAH FACILITY.