FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dorsal Root Ganglion Stimulator For Pain Relief
PMA: P150004
·
Supplement: S032
·
Decision Nov 19, 2019
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Axium Neurostimulator System
- PMA Number
- P150004
- Supplement Number
- S032
- Device Class
- FDA Class 3
- Product Code
- PMP
- Generic Name
- Dorsal root ganglion stimulator for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- November 19, 2019
- Date Received
- October 21, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Changes in the viable air sampling method and a corresponding change to the action and alert limits for the airborne microbes in the controlled access environments(CAE).
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 |
|---|---|---|---|
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | FDA class 3 | Unknown |