|
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 | S001 |
Date Received | 11/18/2013 |
Decision Date | 12/18/2013 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Clinical Trials | NCT00264810
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A SECONDARY COMPONENT SUPPLIER. |
Post-Approval Study | Show Report Schedule and Study Progress |