PMA P150036S056
- Device
- Edwards INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S056
- Product code
- LWR
- Decision date
- 2021-09-08
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Reduction of the number of in-process glutaraldehyde solution change-outs for surgical pericardial heart valves.
Current openFDA PMA Record#
- Device
- Edwards INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S056
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-09-08
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of the number of in-process glutaraldehyde solution change-outs for surgical pericardial heart valves.