FDA.reportPublic FDA data

Sentus ProMRI OTW QP L-85

Primary DI
04035479138448
Brand
Sentus ProMRI OTW QP L-85
Company
BIOTRONIK SE & Co. KG
Model
401183
Catalog number
401183
Published
2019-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P070008079
P070008129

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070008079STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADBiotronik, Inc.2008-05-12NKE
P070008129STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADBiotronik, Inc.2008-05-12NKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479138448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479138448040354791384484035479138448

GMDN Terms#

Term, Definition table
TermDefinition
Coronary venous pacing leadA sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Combination product
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27
04035479116668Selectra Amplatz 6.0-553755203755202014-08-27
04035479116675Selectra BIO2-453755233755232014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734510196Quartet™ST. JUDE MEDICAL, INC.OJX2025-10-02
04035479138400Sentus ProMRI OTW QP S-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138417Sentus ProMRI OTW QP S-85BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138424Sentus ProMRI OTW QP S-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138431Sentus ProMRI OTW QP L-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138455Sentus ProMRI OTW QP L-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479145613Sentus ProMRI OTW QP S-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
04035479148966Sentus ProMRI OTW QP L-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
00643169860414Attain Stability™ Quad MRI SureScan™MEDTRONIC, INC.OJX2019-05-26
00643169860421Attain Stability™ Quad MRI SureScan™MEDTRONIC, INC.OJX2019-05-26
04035479145590Sentus ProMRI OTW QP S-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479145606Sentus ProMRI OTW QP S-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148942Sentus ProMRI OTW QP L-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148959Sentus ProMRI OTW QP L-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
05414734502603Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502610Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502627Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734506823SJM™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734510172Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
05414734510189Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
00643169860223Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860230Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860025Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860032Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860124Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860131Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169601765Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601772Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601789Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601796Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26