- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S018
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-02-28
- Decision code
- APPR
- Date received
- 2012-11-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.