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 NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S001 |
Date Received | 07/02/2015 |
Decision Date | 09/19/2016 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Clinician Programmer App (Version 3.1) Model 3874, Programmer App (Version 3.1) Model 3875, and the Infinity Neurostimulation System. |
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