PMA P150036S046
- Device
- Edwards Intuity Elite Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S046
- Product code
- LWR
- Decision date
- 2019-11-14
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Addition of the Draper, UT site for delivery system manufacturing.
Current openFDA PMA Record#
- Device
- Edwards Intuity Elite Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S046
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-11-14
- Decision code
- OK30
- Date received
- 2019-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of the Draper, UT site for delivery system manufacturing.