PMA P220025S004
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- PMA number
- P220025
- Supplement
- S004
- Product code
- QWN
- Decision date
- 2024-12-20
- Classification
- Cardiovascular
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Approval order statement
- the use of an additional sterilization chamber for ethylene oxide sterilization at the current contract sterilization facility.
Current openFDA PMA Record#
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- PMA number
- P220025
- Supplement
- S004
- Product code
- QWN
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Decision date
- 2024-12-20
- Decision code
- APPR
- Date received
- 2024-07-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of an additional sterilization chamber for ethylene oxide sterilization at the current contract sterilization facility.