- Device
- Ascendra+ Delivery System, NovaFlex+ Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S111
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-09-07
- Decision code
- OK30
- Date received
- 2020-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications in cleanroom entry pathways and shifting manufacturing lines between cleanrooms for improved operational efficiency.