FDA.reportPublic FDA data

Capsure® VDD-2

Primary DI
00613994250148
Brand
Capsure® VDD-2
Company
MEDTRONIC, INC.
Model
5038S-58
Device description
LEAD 5038S-58 US FPA PASS QUAD SILIC
Published
2014-09-23
Public version status
Update
Distribution status
Not 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
DTBpermanent pacemaker Electrode
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003050SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994250148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994250148006139942501486139942501480613994250148

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial 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 pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. 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
Length58Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169708686Adapta™ LMEDTRONIC, INC.NVN2017-10-20
00643169709041Adapta™MEDTRONIC, INC.NVN2017-10-20
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVN2017-06-02
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169633742CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVN2017-06-02
00643169633759CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVN2017-06-02
00643169633759CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169633766CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVN2017-06-02
00643169633773CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169633780CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169857674SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2017-05-21
00643169857681SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2017-05-21
00643169857698SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2017-05-21
00643169860025Attain Ability™ MRI SureScan™MEDTRONIC, INC.DTB2017-03-24
00643169860124Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.DTB2017-03-24
00643169860131Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.DTB2017-03-24
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169410947CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-02-05
00643169410947CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169708174CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2016-12-26
00643169708181CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVN2016-12-26
00643169708198CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVN2016-12-26