FDA.reportPublic FDA data

ESSENTIO™ MRI SR

Primary DI
00802526558948
Brand
ESSENTIO™ MRI SR
Company
BOSTON SCIENTIFIC CORPORATION
Model
L110
Catalog number
L110
Device description
Pacemaker
Published
2016-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWPImplantable pulse generator, pacemaker (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150012000
P150012004
P150012013
P150012021
P150012033
P150012034
P150012042
P150012060
P150012062
P150012068
P150012080
P150012100
P150012112
P150012129
P150012132
P150012134
P150012156
P150012168
P150012173

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150012000IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012004IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012013IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012021IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012033IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012034IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012042IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012060IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012062IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012068IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012080IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012100IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012112IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012129IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012132IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012134IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012156IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012168IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012173IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526558948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526558948008025265589488025265589480802526558948

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable pacemaker, rate-responsiveA sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

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