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 | Genesis Neurostimulation System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S170 |
Date Received | 12/17/2020 |
Decision Date | 02/03/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Use of an alternate component supplier Deringer-Ney Inc (DNI) for the electrodes used in Penta Lamitrode Leads, Models 3227, 3228, & 3229. DNI, will stamp the electrodes instead of machine the electrodes to tighter tolerance values. |
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