FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Low Electric Field, Tumor Treatment
PMA: P100034
·
Supplement: S014
·
Decision Feb 9, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Stimulator, Low Electric Field, Tumor Treatment
- Trade Name
- NOVOCURE'S OPTUNE SYSTEM
- PMA Number
- P100034
- Supplement Number
- S014
- 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
- February 9, 2016
- Date Received
- August 21, 2015
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
Approval of the following changes to the post-approval study for the device: modification to enrollment criteria.
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 |