- Device
- Sapien 3 Transcatheter Heart Valve and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S108
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-03-05
- Decision code
- OK30
- Date received
- 2020-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an alternate ethylene oxide (EO) sterilization cycle at a previously approved sterilization site for the Crimper Model 9600CR.