PMA P220025
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- Product code
- QWN
- Decision date
- 2026-01-07
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Approval order statement
- a manufacturing process change for the soft tip bond
Current openFDA PMA Record#
- Device
- LimFlow System
- Applicant
- LimFlow, Inc.
- PMA number
- P220025
- Supplement
- S008
- Product code
- QWN
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Decision date
- 2026-01-07
- Decision code
- OK30
- Date received
- 2025-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing process change for the soft tip bond