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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.
 
DeviceINFINITY FAMILY OF DBS IPGS AND DBS EPG
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS010
Date Received12/11/2015
Decision Date10/03/2016
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Clinician Programmer App (Version 3.2) Model 3874, Programmer App (Version 3.2) Model 3875 (P140009), and the Protégé/Prodigy/Proclaim Elite family of SCS IPGs and SCS EPG (P010032) which includes the following components:1) IPGs: Protégé (Models 3789), Prodigy (Model 3799), Protégé MRI (Model 377l), Prodigy MRI (Model 3772), and Proclaim 5 Elite (Model 3660); 2) Proclaim 7 Elite (Model 3662) SCS EPG Model 3599; 3) Patient Programmer Models 3855 and 3856; 4) Rapid Programmer Model 3834 (Version 3.7); 5) Clinician Programmer App Model 3874 (Version 3.2); and 6) Patient Controller App Model 3875 (Version 3.2).
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