FDA.reportPublic FDA data

Tendril™

Primary DI
05414734502870
Brand
Tendril™
Company
ST. JUDE MEDICAL, INC.
Model
STS
Catalog number
2088TC-46
Device description
Pacing Lead
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960013046
P960013083
P960013098
P960013118

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960013046TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN
P960013083TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN
P960013098TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN
P960013118TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734502870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734502870054147345028705414734502870

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
Length46Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Storage excursions permitted from 59°- 86° F (15°- 30°C).
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
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
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05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

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Primary DI, Brand, Company table
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04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
08031527019819VegaMICROPORT CRM SRLNVN2023-06-26
08031527019826VegaMICROPORT CRM SRLNVN2023-06-26
08031527019833VegaMICROPORT CRM SRLNVN2023-06-26
08031527019789VegaMICROPORT CRM SRLNVN2023-06-23
08031527019796VegaMICROPORT CRM SRLNVN2023-06-23
08031527019802VegaMICROPORT CRM SRLNVN2023-06-23
05415067046314UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046321UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046338UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046345UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
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00802526604577INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11