FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dorsal Root Ganglion Stimulator For Pain Relief
PMA: P150004
·
Supplement: S055
·
Decision Feb 17, 2022
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Dorsal Root Ganglion (DRG) System
- PMA Number
- P150004
- Supplement Number
- S055
- 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
- February 17, 2022
- Date Received
- January 18, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Additional heat sealer (Accu Seal 6400 series) for use in the Plano facility.
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 |