PMA P150036S064
- Device
- EDWARDS INTUITY Elite Valve System
- Applicant
- EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS064 Date Received08/25/2022 Decision Date09/23/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P150036
- Supplement
- S064
- Product code
- LWR
- Decision date
- 2022-09-23
- Generic name
- Heart-valve, Non-allograft Tissue
Current openFDA PMA Record
- Device
- EDWARDS INTUITY Elite Valve System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S064
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-09-23
- Decision code
- OK30
- Date received
- 2022-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an enhanced temperature indicator packaging component to monitor surgical and transcatheter heart valves during transit and storage.