PMA P150036S010
- Device
- Edwards Intuity Elite Valve & Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S010
- Product code
- LWR
- Decision date
- 2017-05-25
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Manufacturing line change and use of APFO-free resin for manufacturing PTFE components of the INTUITY Elite valve.
Current openFDA PMA Record#
- Device
- Edwards Intuity Elite Valve & Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S010
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-05-25
- Decision code
- OK30
- Date received
- 2017-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing line change and use of APFO-free resin for manufacturing PTFE components of the INTUITY Elite valve.