|
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 | S038 |
Date Received | 10/06/2015 |
Decision Date | 11/05/2015 |
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 THE USE OF AN ALTERNATE EPOXY ADHESIVE (EPOXY TECHNOLOGY EPO-TEK 301 EPOXY) DURING THE MANUFACTURING OF A COMPONENT FOR THE DEPTH AND CORTICAL STRIP LEADS. |