PMA P220025S003
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- PMA number
- P220025
- Supplement
- S003
- Product code
- QWN
- Decision date
- 2024-04-19
- Classification
- Cardiovascular
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Approval order statement
- the addition of 6 new Ethylene Oxide sterilization chambers
Current openFDA PMA Record#
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- PMA number
- P220025
- Supplement
- S003
- Product code
- QWN
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Decision date
- 2024-04-19
- Decision code
- OK30
- Date received
- 2024-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of 6 new Ethylene Oxide sterilization chambers