FDA.reportPublic FDA data

CELERITY

Primary DI
04035479143237
Brand
CELERITY
Company
BIOTRONIK SE & Co. KG
Model
3D 85
Catalog number
382961
Published
2014-08-19
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
P070008027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070008027STRATOS 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
04035479143237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479143237040354791432374035479143237

GMDN Terms#

Term, Definition table
TermDefinition
Coronary venous pacing leadAn 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

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 Temperature0 Degrees Fahrenheit77 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
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

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