PMA P150004S090

Device: Dorsal Root Ganglion (DRG) Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S090
Product code: PMP
Decision date: 2025-11-07
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order 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.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S090
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2025-11-07
Decision code: APPR
Date received: 2025-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.