PMA P150048S053
- Device
- RESILIA Solutions System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S053
- Product code
- LWR
- Decision date
- 2021-04-15
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Implementation of an automated solution mixing, storage, and distribution system for RESILIA solutions.
Current openFDA PMA Record#
- Device
- RESILIA Solutions System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S053
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-04-15
- Decision code
- OK30
- Date received
- 2021-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated solution mixing, storage, and distribution system for RESILIA solutions.