FDA.reportPublic FDA data

TW

Primary DI
04035479145286
Brand
TW
Company
BIOTRONIK SE & Co. KG
Model
108984
Catalog number
108984
Published
2014-08-25
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
DXYimplantable pacemaker Pulse-generator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023000PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479000875PackageGS15In Commercial Distribution
04035479145286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479000875040354790008754035479000875
04035479145286040354791452864035479145286

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead setscrewA sterile device designed to secure the attached pacing lead terminal(s) in the header connector (connection socket) of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure. It is typically made of high-grade stainless steel or titanium (Ti). The device is typically available in a set of graduated sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04035479183066Rivacor Rise VR-T4820204820202026-04-20
04035479185695Rivacor Aura VR-T DX4871994871992026-04-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067050045Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.DXY2024-11-13
08031527018997BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019000BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019017BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019024BlueSkyMICROPORT CRM SRLDXY2023-06-23
05415067040404NAST. JUDE MEDICAL, INC.DXY2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
00763000181215NAMEDTRONIC, INC.DXY2021-05-14
00763000307660NAMEDTRONIC, INC.DXY2020-07-05
00763000059477NAMEDTRONIC, INC.DXY2018-12-28
05414734006880Identity™ST. JUDE MEDICAL, INC.DXY2017-02-06
05414734006811Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006910Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734009553Victory™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734010474Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006828Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
05414734006903Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
00643169838604NAMEDTRONIC, INC.DXY2016-10-08