NeuroPace® Patient Data Management System (PDMS)

Primary DI
00855547005007
Brand
NeuroPace® Patient Data Management System (PDMS)
Company
Neuropace, Inc.
Model
Model 4340
Device description
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.
Published
2015-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFNImplanted Brain Stimulator For Epilepsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFNImplanted Brain Stimulator For EpilepsyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100026000
P100026036
P100026047
P100026082
P100026090

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100026000NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026036NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026047NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026082NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN
P100026090NEUROPACE RNS SYSTEMNeuroPace, Inc.2013-11-14PFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855547005007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855547005007008555470050078555470050070855547005007

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-726-3876customerservice@neuropace.com

Regulatory Flags#

DUNS number
123369238
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855547005205Burr Hole Cover81102016-08-23
00855547005427NeuroPace® Remote Monitor Kit51072023-11-14
00855547005434NeuroPace® Remote Monitor Kit51072023-11-14
00855547005281RNS® Tablet Kit50012018-01-15
00855547005366RNS® Neurostimulator KitRNS-320-K2020-03-10
00855547005410Explant KitEX-01-K2022-02-22
00855547005137MagnetM-012014-09-24
00855547005403Remote Monitor Phone Accessories51042020-09-14
00855547005250NeuroPace® Remote Monitor Kit51012018-05-18
00855547005113WandW-022014-09-24
00855547005120RNS® Neurostimulator KitRNS-300M-K2017-12-18
00855547005267RNS® Neurostimulator KitRNS-320-K2018-05-18
00855547005373Ferrule KitF-01-K2020-03-16
00855547005380Craniectomy Template KitCT-01-K2020-03-16
00855547005397Connector Cover KitCC-01-K2020-03-16
00855547005298NeuroPace® Depth Lead KitDL-344-10-K2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitCL-335-10-K2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitCL-325-10-K2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitCL-315-10-K2020-03-15
00855547005335NeuroPace® Depth Lead KitDL-330-10-K2020-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855547005427NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005434NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2023-11-14
00855547005410Explant KitNeuropace, Inc.PFN2022-02-22
00855547005403Remote Monitor Phone AccessoriesNeuropace, Inc.PFN2020-09-14
00855547005373Ferrule KitNeuropace, Inc.PFN2020-03-16
00855547005380Craniectomy Template KitNeuropace, Inc.PFN2020-03-16
00855547005397Connector Cover KitNeuropace, Inc.PFN2020-03-16
00855547005298NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2020-03-15
00855547005335NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005342NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005359NeuroPace® Depth Lead KitNeuropace, Inc.PFN2020-03-15
00855547005366RNS® Neurostimulator KitNeuropace, Inc.PFN2020-03-10
00855547005250NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005243NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2018-05-18
00855547005267RNS® Neurostimulator KitNeuropace, Inc.PFN2018-05-18
00855547005281RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005274RNS® Tablet KitNeuropace, Inc.PFN2018-01-15
00855547005120RNS® Neurostimulator KitNeuropace, Inc.PFN2017-12-18
00855547005083NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005090NeuroPace® Remote Monitor KitNeuropace, Inc.PFN2014-09-24
00855547005106NeuroPace® Programmer KitNeuropace, Inc.PFN2014-09-24
00855547005014NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005021NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005038NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005045NeuroPace® Depth Lead KitNeuropace, Inc.PFN2014-09-24
00855547005052NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2014-09-24
00855547005069NeuroPace® Cortical Strip Lead KitNeuropace, Inc.PFN2014-09-24