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 | NeuroPace RNS System |
Generic Name | Implanted brain stimulator for epilepsy |
Applicant | NEUROPACE INC 455 N. BERNARDO AVE MOUNTAIN VIEW, CA 94043 |
PMA Number | P100026 |
Supplement Number | S047 |
Date Received | 02/15/2017 |
Decision Date | 08/14/2017 |
Product Code |
PFN |
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 Neurostimulator (model RNS-320), NeuroPace Programmer (model 5000), Patient Data Management System (PDMS, model 4340), and Remote Monitor (model 5100). |
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