ProSorba Column
by Fresenius Hemocare, Inc. PMA
Withdrawn
PMA P850020
Overview
The ProSorba Column is a membrane automated blood cell/plasma separator, classified as a Class III device under FDA regulations. It is designed for therapeutic applications involving the separation of blood components, facilitating the extraction of plasma while retaining cellular elements.
This device is supplied as a single-use component, intended for use in medical settings such as dialysis or apheresis procedures. Authorized under FDA PMA (P850020), it adheres to strict regulatory standards and is intended for automated blood processing systems. No MRI safety or reusable specifications are noted in the data.
Regulatory status
Withdrawn since 23 Dec 1987. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP850020 | Date23 Dec 1987 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
-
- Terminated Z-1086-03
No package insert
Specification
- Trade Name
- Prosorba(Tm) Column
- Generic Name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- PMA Number
- FDA Product Code
- MDP
- Device Class
- Class III
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APWD Approval withdrawn
Questions
What clinical procedures is the ProSorba Column intended to support within a medical setting?
The ProSorba Column is designed for therapeutic blood processing procedures, specifically automated blood cell/plasma separation. It is used in systems where plasma is extracted while cellular elements are retained, commonly applied in dialysis or apheresis therapies to treat conditions requiring plasma manipulation, such as toxin removal or immune modulation.
Is the ProSorba Column reusable, or is it meant for single-use only?
The ProSorba Column is explicitly supplied as a single-use component, meaning it is intended for one-time use in automated blood processing systems. This design ensures patient safety and sterility, as reuse is not authorized or supported by the manufacturer.
What regulatory pathway does the ProSorba Column follow, and how does this affect its use?
The ProSorba Column is authorized under the FDA’s Premarket Approval (PMA) pathway, with the approval number **P850020**. This means it has undergone rigorous review to demonstrate safety and effectiveness for its intended therapeutic separation of blood components, ensuring compliance with strict regulatory standards before clinical use.
Are there multiple sizes or models of the ProSorba Column, or is it available in a single configuration?
The provided data does not specify distinct sizes or models of the ProSorba Column beyond its classification as a membrane automated blood cell/plasma separator. However, the device is listed under multiple **FEI numbers** (e.g., 3002807204, 3010383847), which may indicate variations in design or compatibility with different automated systems. Clarification from the manufacturer would be needed to confirm exact configurations.
How should the ProSorba Column be stored to maintain its integrity before use?
While specific storage instructions aren’t detailed in the data, the ProSorba Column is a single-use medical device intended for sterile use in controlled environments like dialysis or apheresis centers. It should be stored in its original packaging, protected from contamination, moisture, and extreme temperatures to preserve sterility and functionality until use.