- Device
- EDWARDS INTUITY Valve System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S022
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-06-13
- Decision code
- APPR
- Date received
- 2017-11-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change from a manual to semi-automated process for ironing polyethylene terephthalate cloth used on pericardial valves.