Identity
- Trade Name
- LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). FDA PMA
- Generic Name
- Lipoprotein, low density, removal FDA PMA
Identifiers
- PMA Number
- P910018 FDA PMA
- FDA Product Code
- MMY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Liposorber LA-15 System is a low density lipoprotein (LDL) apheresis system designed for the removal of LDL from plasma. It consists of an adsorption column, plasma separator, and tubing system for plasmapheresis.
The system is supplied as a configured set including the Liposorber LA-15 adsorption column, Sulfox FS-05 plasma separator, and tubing system. It is intended for use in clinical settings under medical supervision and is authorized under FDA Premarket Approval (PMA) number P910018.
Frequently asked questions
What is the Liposorber LA-15 System used for?
The Liposorber LA-15 System is used for low density lipoprotein (LDL) apheresis, which involves the removal of LDL from plasma as part of extracorporeal blood treatment.
Who manufactures the Liposorber LA-15 System?
The Liposorber LA-15 System is manufactured by Kaneka Pharma America Corp., as stated in the device data and authorization records.
What regulatory authorization does the Liposorber LA-15 System have?
The Liposorber LA-15 System has FDA Premarket Approval (PMA) under number P910018, as indicated in the AUTHORIZATIONS and openfda fields of the device data.
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 | P910018 | Class III | Active |
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Manufacturer
- Manufacturer
- Kaneka Pharma America Corp.
Sources (1)
- FDA PMA P910018 24 fields · synced Sep 18, 2026