OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
FDA premarket approval P100034/S013 · decided 2015-10-05
Approval details
- PMA number
- P100034
- Supplement
- S013
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2015-04-10
- Decision date
- 2015-10-05
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- 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 F
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