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 | BRIO NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S024 |
Date Received | 06/02/2017 |
Decision Date | 06/28/2017 |
Product Codes |
MHY NHL PJS |
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 Software update to the Automated Test Equipment (ATE) that will set the value of Open Threshold and Switch Threshold for all Proclaim, Infinity, and Proclaim DRG devices to a constant value of 253 during manufacturing instead of calculating the trim value using a formula. |
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