- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S003
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative crimping accessory packaged with the Edwards delivery systems.