FDA.reportPublic FDA data

CapSure Sense®

Primary DI
00643169590489
Brand
CapSure Sense®
Company
MEDTRONIC, INC.
Model
407345
Device description
LEAD 407345 US UNI RCMCRD
Published
2016-04-24
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
NVYPermanent defibrillator electrodes

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P830061113

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P830061113STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGMedtronic Cardiac Rhythm Disease Management1986-07-29NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169590489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169590489006431695904896431695904890643169590489

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
Length45Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 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
Primary DIBrandModelCatalogPublished
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479177041Solia CSP S 60BIOTRONIK SE & Co. KGNVN2026-02-17
04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
04035479106232SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106249SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106256SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106263SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118280SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118297SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479132606SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479136567SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479157821EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVN2017-06-02
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
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
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05