- Device
- Deep Brain Stimulation (DBS) Neurostimulation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S124
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- 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.