PMA P150036S062
- Device
- Edwards INTUITY ELITE Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S062
- Product code
- LWR
- Decision date
- 2022-04-20
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Add a new supplier to perform the e-beam dose audits for Edwards INTUITY ELITE Delivery System.
Current openFDA PMA Record#
- Device
- Edwards INTUITY ELITE Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S062
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-04-20
- Decision code
- OK30
- Date received
- 2022-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new supplier to perform the e-beam dose audits for Edwards INTUITY ELITE Delivery System.