FDA.reportPublic FDA data

NEUROPACE

Matched from indexed company URL: NeuroPace, Inc.

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00855547005007NeuroPace® Patient Data Management System (PDMS) - The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.1-866-726-3876customerservice@neuropace.com
00855547005137Magnet - The Magnet package contains 1 Magnet.+1(866)726-3876customerservice@neuropace.com

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

PMA#

NeuroPace® RNS® System

2022-12-29

NEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS091 Date Received09/26/2022 Decision Date12/29/2022 Product Code PFN  Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

NeuroPace RNS System

2022-07-28

NEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS090 Date Received04/29/2022 Decision Date07/28/2022 Product Code PFN  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/c...

79 records. Showing 1-40. Next

PMN#

GUDID#

42 records. Showing 1-40. Next