FDA.reportPublic FDA data

NEUROPACE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044266593004426659NEUROPACE1N2026-01-01455 N. Bernardo Avenue Mountain View CA US 94043

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1593392056022208P100026NEUROPACE RNS SYSTEMPFN2013-11-14
1593391233733695K141368NEUROPACE BURR HOLE COVERGXR2014-07-11
1593391489272949K123163NEUROPACE BURR HOLE COVER MODEL 8110GXR2013-01-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXR22014-07-11
PFN12013-11-14