Identity
- Trade Name
- PLASMA SEPARATION SYSTEM FDA PMA
- Generic Name
- CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES FDA PMA
Identifiers
- PMA Number
- P820032 FDA PMA
- FDA Product Code
- LMN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APWD FDA PMA
This device is a Plasma Separation System, designed for the separation of plasma from whole blood or blood components. It employs a specialized filtration process to isolate plasma, which is critical for therapeutic applications such as plasma-derived product manufacturing or transfusion medicine.
The system is intended for use in clinical or laboratory settings, supplied sterile for single-use. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) under the designation P820032. No MRI safety information is provided, and storage conditions are not specified in the available data.
Frequently asked questions
What is the Plasma Separation System from Fenwal, Inc. used for in clinical settings?
The Plasma Separation System is designed specifically to separate plasma from whole blood or blood components using a filtration process. This is essential for applications like manufacturing plasma-derived products or preparing plasma for transfusion, ensuring the isolated plasma meets requirements for therapeutic use.
Is the Plasma Separation System intended for repeated use, or is it meant to be used only once?
The Plasma Separation System is supplied sterile for single-use only, meaning it is not designed to be reused after a single procedure. This ensures patient safety and maintains sterility standards in clinical or laboratory environments.
How is the Plasma Separation System regulated by the FDA, and what does that mean for its use?
The Plasma Separation System is classified as a Class III medical device under FDA regulations, requiring a Premarket Approval (PMA) with the designation P820032. This classification indicates it undergoes rigorous review to ensure safety and effectiveness before clinical or laboratory use, as it directly impacts blood processing for therapeutic applications.
Are there specific storage instructions provided for the Plasma Separation System?
The available data does not include explicit storage conditions for the Plasma Separation System. Clinicians or facilities using this device should follow general sterile medical device storage guidelines until specific manufacturer instructions are provided, as improper storage could compromise performance or sterility.
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 | P820032 | U | Active |
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Manufacturer
- Manufacturer
- Fenwal, Inc.
Sources (1)
- FDA PMA P820032 24 fields · synced Sep 18, 2026