Dorsal Root Ganglion Stimulator For Pain Relief
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Basic Information
- Device Name
- Dorsal Root Ganglion Stimulator For Pain Relief
- Trade Name
- Dorsal Root Ganglion (DRG) Neurostimulation System
- PMA Number
- P150004
- Supplement Number
- S090
- Device Class
- FDA Class 3
- Product Code
- PMP
- Generic Name
- Dorsal root ganglion stimulator for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 7, 2025
- Date Received
- August 11, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
for following changes related to the Patient Magnet, which is an external medical device accessory. 1) Design Modifications: Magnet shape, Magnet Enclosure, Foam, Keeper covers and Keeper sheet (from stainless steel coated with epoxy to carbon steel)2) Material Update: Raw Magnet material change from Alloy of Aluminum-Nickel-Cobalt to Neodymium; Addition of Magnet Enclosures and Keeper covers made of Sabic Cycoloy HC1204HF, Polycarbonate (PC) and Acrylonitrile-butadiene-styrene (ABS) blend. 3) Suppliers Change: Current Suppliers: o Raw magnet and keeper sheet Hangzhou Yang Yi Magnetics Co., Ltd. o Magnet and Keeper assembly: Specialty Coating System New Suppliers: o Raw magnet and keeper sheet Dongguan Jiada Magnet Co., Ltd o Foam: AJR Enterprises o Magnet, Magnet Enclosure and Keeper assembly: Eptam Precision Molding.
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 |