PMA P150036S080
- Device
- EDWARDS INTUITY Elite Valve, Model 8300AB
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S080
- Product code
- LWR
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- a new sampling plan for in-process testing
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY Elite Valve, Model 8300AB
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S080
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sampling plan for in-process testing