Identity
- Trade Name
- LimFlow System FDA PMA
- Generic Name
- Stent graft, infrapopliteal, venous arterialization FDA PMA
Identifiers
- PMA Number
- P220025 FDA PMA
- FDA Product Code
- QWN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The LimFlow System is a stent graft designed for infrapopliteal venous arterialization. It is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
The device is supplied by Limflow Inc. and has received FDA PMA approval (P220025). It is intended for use in clinical settings as specified in the authorization, with no additional details on sterility, single-use status, MRI safety, sizes, or storage provided in the data.
Frequently asked questions
What is the LimFlow System indicated for?
The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation, as stated in the approval documentation.
What type of device is the LimFlow System classified as?
The LimFlow System is classified as a stent graft for infrapopliteal venous arterialization, based on its generic name and device name in the openfda field.
Has the LimFlow System received regulatory approval?
Yes, the LimFlow System has received FDA PMA approval, with the application number P220025 and a decision date of September 11, 2023.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P220025 | Class III | Active |
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Manufacturer
- Manufacturer
- Limflow Inc.
- FDA Applicant
- LimFlow, Inc.
Sources (1)
- FDA PMA P220025 23 fields · synced Sep 18, 2026