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 | S044 |
Date Received | 10/17/2016 |
Decision Date | 11/16/2016 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Move the location of the laser and resistance welding processes for neurostimulator and ferrule components to their new manufacturing facility in a NeuroPace’s approved sub-contractor, Cirtec Medical Systems (Cirtec), in Enfield, Connecticut. |
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