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 | MHY |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S022 |
Date Received | 11/07/2016 |
Decision Date | 02/03/2017 |
Product Codes |
MHY NHL PJS |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of an updated version (v 3.4) of Clinician Programmer and Patient Controller software to enable the Surgery Mode and Device Status Check features in the Proclaim Elite, Infinity, and Proclaim DRG family of implanted pulse generators (IPGs). |
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