|
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 | S028 |
Date Received | 01/13/2015 |
Decision Date | 04/08/2015 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO STATE THE CALCULATED BATTERY LIFECONSISTENTLY THROUGHOUT THE INSTRUCTION MANUALS. |