FDA.reportPublic FDA data

Tendril™

Primary DI
05414734501705
Brand
Tendril™
Company
ST. JUDE MEDICAL, INC.
Model
ST
Catalog number
1888TC-58
Device description
Pacing Lead
Published
2017-02-03
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
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960013018
P960013083

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960013018TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN
P960013083TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734501705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734501705054147345017055414734501705

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length58Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067057341Navitor™NVRO-35NVRO-352026-11-05
05415067057365Navitor™NVRO-29NVRO-292026-11-05
05415067057389Navitor™NVRO-27NVRO-272026-11-05
05415067057402Navitor™NVRO-25NVRO-252026-11-05
05415067057426Navitor™NVRO-23NVRO-232026-11-05
05415067057242Amplatzer™9-APVL-1439-APVL-1432026-11-02
05415067057259Amplatzer™9-APVL-0849-APVL-0842026-11-02
05415067057266Amplatzer™9-APVL-1239-APVL-1232026-11-02
05415067057273Amplatzer™9-APVL-0639-APVL-0632026-11-02
05415067057280Amplatzer™9-APVL-1059-APVL-1052026-11-02
05415067057297Amplatzer™9-APVL-0429-APVL-0422026-11-02
05415067057303Amplatzer™9-APVL-1039-APVL-1032026-11-02
05415067057310Amplatzer™9-APVL-1259-APVL-1252026-11-02
05415067057327Amplatzer™9-APVL-1459-APVL-1452026-11-02
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000369743Epsila EV™MEDTRONIC, INC.NVY2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000571528NAMEDTRONIC, INC.NVY2023-07-30
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2022-12-11
00763000059385NAMEDTRONIC, INC.NVY2018-12-22
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00802526496868RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496967RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496981RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526497001RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592805RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592829RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592850RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592867RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26