PMA P200015S012
- Device
- SAPIEN 3 Transcatheter Heart Valve and Accesssories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S012
- Product code
- NPV
- Decision date
- 2021-08-31
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Change to the receiving inspection for the Final Stopper component of the Crimp Stopper.
Current openFDA PMA Record#
- Device
- SAPIEN 3 Transcatheter Heart Valve and Accesssories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S012
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the receiving inspection for the Final Stopper component of the Crimp Stopper.