| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Spinal Cord Stimulation (SCS) Neurostimulation System |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | ABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024 |
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| PMA Number | P010032 |
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| Supplement Number | S243 |
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| Date Received | 08/11/2025 |
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| Decision Date | 11/07/2025 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
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