PMA P150036S053
- Device
- EDWARDS INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S053
- Product code
- LWR
- Decision date
- 2020-11-10
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modifications to the Solutions Mixing Clean Room in the Singapore facility.
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S053
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-11-10
- Decision code
- OK30
- Date received
- 2020-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the Solutions Mixing Clean Room in the Singapore facility.