PERCIVA™ ICD DR

GUDID 00802526587955

Implantable Cardioverter Defibrillator DR

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator
Primary Device ID00802526587955
NIH Device Record Key687b7631-0c20-4487-bad5-11fefb619dac
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERCIVA™ ICD DR
Version Model NumberD413
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100802526587955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-06
Device Publish Date2017-09-27

On-Brand Devices [PERCIVA™ ICD DR]

00802526587955Implantable Cardioverter Defibrillator DR
00802526587894Implantable Cardioverter Defibrillator DR

Trademark Results [PERCIVA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERCIVA
PERCIVA
86961495 5454084 Live/Registered
Cardiac Pacemakers, Inc.
2016-04-01

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