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 | INFINITY FAMILY OF DBS IPGS AND DBS EPG |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S010 |
Date Received | 12/11/2015 |
Decision Date | 10/03/2016 |
Product Codes |
MHY NHL |
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 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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