PMA
P100034: NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
FDA PMA · Stimulator, low electric field, tumor treatment · Novocure, GmbH
Key facts
| PMA number | P100034 |
|---|---|
| Trade name | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
| Generic name | Stimulator, low electric field, tumor treatment |
| Applicant | Novocure, GmbH |
| Owner/operator | Novocure Ltd |
| Product code | NZK |
| Approval date | Apr 8, 2011 |
| Docket number | 11M-0295 |
| Notice date | May 6, 2011 |
| Establishment registration | 3009453079 |
| FEI number | 3009453079 |
At a glance
- 10–99 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: