Precision Montage™

GUDID 08714729907091

Implantable Pulse Generator and Charging Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID08714729907091
NIH Device Record Keyd0d91758-c213-46b0-af29-64f63cc58de4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Montage™
Version Model NumberSC-1020
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729907091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-12-17
Device Publish Date2016-05-03

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