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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceDEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS015
Date Received06/06/2016
Decision Date11/28/2016
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664 Proclaim DRG IPG7108 Port PlugMN15000 Tunneling Tool KitNot applicable Torque WrenchNot applicable Pocket SizerMN10450-50 Implant Lead Kit, 50cmMN10450-50A Implant Lead Kit, SlimTip, 50cmNot applicable Soft Tissue AnchorMN12050 Lead Accessory Kit3874 St. Jude Medical Clinician Programmer App3875 St. Jude Medical Patient Controller App
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