Stimulator, Low Electric Field, Tumor Treatment
Basic Information
- Device Name
- Stimulator, Low Electric Field, Tumor Treatment
- Trade Name
- OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
- PMA Number
- P100034
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- NZK
- Generic Name
- Stimulator, low electric field, tumor treatment
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 5, 2015
- Date Received
- April 10, 2015
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 15M-4015
Advisory Committee Statement
APPROVAL FOR THE OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM). THIS DEVICE IS INDICATED AS A TREATMENT FOR ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY-CONFIRMED GLIOBLASTOMA MULTIFORME (GBM). OPTUNE WITH TEMOZOLOMIDE IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED, SUPRATENTORIAL GLIOBLASTOMA FOLLOWING MAXIMAL DEBULKING SURGERY AND COMPLETION OF RADIATION THERAPY TOGETHER WITH CONCOMITANT STANDARD OF CARE CHEMOTHERAPY. OPTUNE WAS PREVIOUSLY APPROVED IN 2011 FOR THE TREATMENT OF RECURRENT GBM WITH THE FOLLOWING INDICATIONS FOR USE (IFU): OPTUNE IS INDICATED FOLLOWING HISTOLOGICALLY-OR RADIOLOGICALLY-CONFIRMED RECURRENCE IN THE SUPRA-TENTORIAL REGION OF THE BRAIN AFTER RECEIVING CHEMOTHERAPY. THE DEVICE IS INTENDED TO BE USED AS A MONOTHERAPY, AND IS INTENDED AS AN ALTERNATIVE TO STANDARD MEDICAL THERAPY FOR GBM AFTER SURGICAL AND RADIATION OPTIONS HAVE BEEN EXHAUSTED.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NZK | Stimulator, Low Electric Field, Tumor Treatment | FDA class 3 | Unknown |