NeuroPace® Patient Data Management System (PDMS)

GUDID 00855547005007

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.

Neuropace, Inc.

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Primary Device ID00855547005007
NIH Device Record Keye92d4ff7-a081-4bf5-9855-c100ad8b4fff
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPace® Patient Data Management System (PDMS)
Version Model NumberModel 4340
Company DUNS123369238
Company NameNeuropace, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com
Phone1-866-726-3876
Emailcustomerservice@neuropace.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PFNImplanted Brain Stimulator For Epilepsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2015-07-22

Devices Manufactured by Neuropace, Inc.

00855547005434 - NeuroPace® Remote Monitor Kit2023-11-22 The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
00855547005410 - Explant Kit2022-03-02 The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
00855547005403 - Remote Monitor Phone Accessories2020-09-22 The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
00855547005373 - Ferrule Kit2020-03-24 The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
00855547005380 - Craniectomy Template Kit2020-03-24 The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
00855547005397 - Connector Cover Kit2020-03-24 The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
00855547005298 - NeuroPace® Depth Lead Kit2020-03-23 The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw
00855547005304 - NeuroPace® Cortical Strip Lead Kit2020-03-23 The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool S

Trademark Results [NeuroPace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUROPACE
NEUROPACE
85420301 not registered Dead/Abandoned
NeuroPace, Inc.
2011-09-12
NEUROPACE
NEUROPACE
78872716 3213127 Live/Registered
NeuroPace, Inc.
2006-04-28
NEUROPACE
NEUROPACE
78872712 3213126 Live/Registered
NeuroPace, Inc.
2006-04-28
NEUROPACE
NEUROPACE
76360887 not registered Dead/Abandoned
NeuroPace, Inc.
2002-01-22
NEUROPACE
NEUROPACE
75401605 2269819 Dead/Cancelled
NEUROPACE, INC.
1997-12-08

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