PMA P150036S002
- Device
- EDWARDS INTUITY VALVE SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S002
- Product code
- LWR
- Decision date
- 2017-06-20
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval of an additional site for manufacturing components used in the Edwards surgical heart valves.
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY VALVE SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S002
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-06-20
- Decision code
- APPR
- Date received
- 2016-12-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of an additional site for manufacturing components used in the Edwards surgical heart valves.