NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
FDA premarket approval P100034 · decided 2011-04-08
Approval details
- PMA number
- P100034
- Trade name
- NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2010-08-16
- Decision date
- 2011-04-08
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Baar
- Statement
- APPROVAL FOR THE NOVOTTF-100A SYSTEM. THE DEVICE IS INDICATED FOR TREATMENT OF ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY- CONFIRMED GLIOBLASTOMA MULTIFORME, FOLLOWING HISTOLOGICALLY- OR RADIOLOGICALLY- CONFIRMED RECURRENCE IN THE SUPRATENTORIAL 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.