NeuroPace® Patient Data Management System (PDMS)

Basic Information

• Brand Name: NeuroPace® Patient Data Management System (PDMS)
• Primary DI: 00855547005007
• Version / Model: Model 4340
• Company Name: Neuropace, Inc.
• Labeler DUNS: 123369238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 6
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: e92d4ff7-a081-4bf5-9855-c100ad8b4fff

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFN	Implanted Brain Stimulator For Epilepsy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
11332	Cannulated surgical drill bit, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855547005007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P100026	000
P100026	036
P100026	047
P100026	082
P100026	090