|
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 | S039 |
Date Received | 11/09/2015 |
Decision Date | 12/09/2015 |
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 ADDITION OF A CLEANING STEP AND CLEANING SOLUTION TO THE MANUFACTURING PROCESS THAT PRODUCES THE LEAD RING MARKER. |