FDA.reportPublic FDA data

CareLink Encore™

Primary DI
00613994909688
Brand
CareLink Encore™
Company
MEDTRONIC, INC.
Model
29901
Device description
PROGRAMMER 29901 CARELINK ENCORE US
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXYimplantable pacemaker Pulse-generator
KRGProgrammer, pacemaker
LWPImplantable pulse generator, pacemaker (non-CRT)
NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
NVZPulse generator, permanent, implantable
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
KRGProgrammer, PacemakerCardiovascular3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003254

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003254SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994909688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994909688006139949096886139949096880613994909688

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator programmerAn external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
00643169552043MyCareLink™MEDTRONIC, INC.OSR2019-10-13
00763000033194MyCareLink™MEDTRONIC, INC.OSR2019-10-13
00763000033217MyCareLink™MEDTRONIC, INC.OSR2019-10-13
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169725379MyCareLink™MEDTRONIC, INC.NVZ2017-11-16
00643169725386MyCareLink™MEDTRONIC, INC.OSR2017-11-16
00643169871922Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871939Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871953Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-11-02
00643169871977Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169708600Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169708686Adapta™ LMEDTRONIC, INC.LWP2017-10-20
00643169709041Adapta™MEDTRONIC, INC.NVZ2017-10-20
00643169709065Sensia™MEDTRONIC, INC.LWP2017-10-20
00643169709072Versa™MEDTRONIC, INC.LWP2017-10-20
00643169720145Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720206Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720312Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720329Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720404Evera™ XT DRMEDTRONIC, INC.NVZ2017-09-15
00643169720497Evera MRI™ XT DR SureScan®MEDTRONIC, INC.NVZ2017-09-15
00643169720619Visia AF™ VRMEDTRONIC, INC.NVZ2017-09-15
00643169837713Evera MRI™ XT DR SureScan™MEDTRONIC, INC.NVZ2017-09-15
00643169837744Evera MRI™ S DR SureScan™MEDTRONIC, INC.NVZ2017-09-15