FDA.reportPublic FDA data

Corox

Primary DI
04035479093532
Brand
Corox
Company
BIOTRONIK SE & Co. KG
Model
OTW 75-BP
Catalog number
354805
Published
2014-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P070008000
P070008070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070008000STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADBiotronik, Inc.2008-05-12NKE
P070008070STRATOS 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
04035479093532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479093532040354790935324035479093532

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment Temperature077 Degrees Fahrenheit

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
04035479116644Selectra Accessory Kit3755183755182014-08-27
04035479177638BIOexpress4692984692982026-10-20
04035479190538SW HMSC 3.664980924980922026-05-28
04035479194406SW HMSC 3.685324265324262026-10-09
04035479190705NEO 2601.U4991024991022026-09-21
04035479190712PSW 2601.U4991034991032026-09-21
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

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
04035479138448Sentus ProMRI OTW QP L-85BIOTRONIK 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