Basic Information
- Number
- TNP/MDR/0016/5009/2023
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- December 28, 2023
- Expiry Date
- December 27, 2026
- Revision
- Ver. 01
- Manufacturer
- Immunicom Inc.
Certificate Lifecycle
Device Characteristics
Conditions
English
Until the clinical trials are finished, the following information about ongoing clinical trials in the Instructions for Use is required: INTENDED PURPOSE / INDICATIONS FOR USE The LW-02 Column is indicated for use with the Spectra Optia® Apheresis System (Terumo BCT, Inc.) to remove soluble Tumor Necrosis Factor Receptors (sTNFRs) 1 and 2 from the plasma of patients ages 18 and older with dvanced, refractory, triple-negative breast cancer. However, the clinical efficacy of the LW02 Column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 Column for this indication are ongoing
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Kolumna do aferezy / Apheresis column
Quality Procedure Scope
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.