FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dorsal Root Ganglion Stimulator For Pain Relief
PMA: P150004
·
Supplement: S025
·
Decision Sep 19, 2018
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Proclaim DRG IPG
- PMA Number
- P150004
- Supplement Number
- S025
- 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
- September 19, 2018
- Date Received
- August 20, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Updated design of the Manufacturing Test Lead which is used for testing the Proclaim Dorsal Root Ganglion Implantable Pulse Generator during the manufacturing process.
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 |