FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Low Electric Field, Tumor Treatment
PMA: P100034
·
Supplement: S039
·
Decision Mar 25, 2025
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Stimulator, Low Electric Field, Tumor Treatment
- Trade Name
- Optune®
- PMA Number
- P100034
- Supplement Number
- S039
- Device Class
- FDA Class 3
- Product Code
- NZK
- Generic Name
- Stimulator, low electric field, tumor treatment
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 25, 2025
- Date Received
- February 28, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the addition of a second supplier for the thermistor component of the HFE Transducer Arrays
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 |