INCEPTA™ CRT-D

GUDID 00802526480997

Cardiac Resynchronization Therapy Defibrillator

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator
Primary Device ID00802526480997
NIH Device Record Keye133711c-9d4c-43a2-b911-bf1f6fb7f750
Commercial Distribution StatusIn Commercial Distribution
Brand NameINCEPTA™ CRT-D
Version Model NumberN160
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
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 Usetrue
Lot Batchfalse
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
GS100802526480997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

On-Brand Devices [INCEPTA™ CRT-D]

00802526481031Cardiac Resynchronization Therapy Defibrillator
00802526481000Cardiac Resynchronization Therapy Defibrillator
00802526480997Cardiac Resynchronization Therapy Defibrillator

Trademark Results [INCEPTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INCEPTA
INCEPTA
85522702 not registered Dead/Abandoned
Sargent Manufacturing Company
2012-01-23
INCEPTA
INCEPTA
76702690 4179596 Dead/Cancelled
Cardiac Pacemakers, Inc.
2010-04-28
INCEPTA
INCEPTA
75904308 not registered Dead/Abandoned
INCEPTA GROUP PLC
2000-01-27
INCEPTA
INCEPTA
75724062 2451887 Dead/Cancelled
INCEPTA LLC
1999-06-07
INCEPTA
INCEPTA
75724061 not registered Dead/Abandoned
INCEPTA LLC
1999-06-07

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