PMA P130009S080
- Device
- Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S080
- Product code
- NPT
- Decision date
- 2017-07-27
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Implement a new minimum load configuration for the EO sterilization cycle at Sterigenics, Salt Lake City, Utah.
Current openFDA PMA Record#
- Device
- Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S080
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2017-07-27
- Decision code
- OK30
- Date received
- 2017-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new minimum load configuration for the EO sterilization cycle at Sterigenics, Salt Lake City, Utah.