PMA P150036S036
- Device
- EDWARDS INTUITY ELITE Valve/Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S036
- Product code
- LWR
- Decision date
- 2018-12-01
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Qualification of the remodeled Life Sciences (LFS) cleanroom to manufacture the INTUITY ELITE delivery system.
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY ELITE Valve/Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S036
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-12-01
- Decision code
- OK30
- Date received
- 2018-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of the remodeled Life Sciences (LFS) cleanroom to manufacture the INTUITY ELITE delivery system.