FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Low Electric Field, Tumor Treatment
PMA: P100034
·
Supplement: S020
·
Decision Oct 19, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Stimulator, Low Electric Field, Tumor Treatment
- Trade Name
- Optune System
- PMA Number
- P100034
- Supplement Number
- S020
- 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
- October 19, 2018
- Date Received
- September 20, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to lead-free solder.
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 |