Identity
- Trade Name
- NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT FDA PMA
- Generic Name
- Stimulator, low electric field, tumor treatment FDA PMA
Identifiers
- PMA Number
- P100034 FDA PMA
- FDA Product Code
- NZK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The NOVO TTF-100A SYSTEM is a stimulator that delivers low electric fields for tumor treatment, specifically indicated for adult patients with histologically confirmed glioblastoma multiforme following recurrence in the supratentorial region of the brain. It is intended as a monotherapy alternative to standard medical therapy after surgical and radiation options have been exhausted.
Supplied as a treatment kit, the device is used under medical supervision in clinical settings. It is a Class III device with FDA PMA authorization (P100034), and its specifications include the exact model designation NOVO TTF-100A SYSTEM as defined in the approval documentation.
Frequently asked questions
What is the NOVO TTF-100A SYSTEM indicated to treat?
The NOVO TTF-100A SYSTEM is indicated for the 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.
How is the NOVO TTF-100A SYSTEM intended to be used in therapy?
The device is intended to be used as a monotherapy and as an alternative to standard medical therapy for glioblastoma after surgical and radiation options have been exhausted.
What regulatory authorization does the NOVO TTF-100A SYSTEM have?
The NOVO TTF-100A SYSTEM has FDA PMA authorization, with the approval documented under PMA number P100034 and decision date April 8, 2011.
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. Sources consulted: Novo Nordisk Pharma GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100034 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novocure GmbH
- FDA Applicant
- Novocure, GmbH
Sources (1)
- FDA PMA P100034 24 fields · synced Sep 18, 2026