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 | S054 |
Date Received | 02/20/2018 |
Decision Date | 05/16/2018 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate smaller size NeuroPace Magnet, a new carabiner style convenience clip to carry the magnet, and minor labeling changes to incorporate new artwork depicting a more generic looking magnet and to add the clip to the contents on the label. |
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