FDA.reportPublic FDA data

CareLink Encore™

Primary DI
00643169369030
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
P890003371

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003254SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ
P890003371SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169369030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169369030006431693690306431693690300643169369030

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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000862336MyCareLink™MEDTRONIC, INC.OSR2026-07-26
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
04035479001575M-50BIOTRONIK SE & Co. KGKRG2024-10-16
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-20
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-03
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-01-10
04035479184285NEOBIOTRONIK SE & Co. KGOSR2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KGOSR2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KGOSR2023-12-15
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13
04035479182960NEOBIOTRONIK SE & Co. KGOSR2023-08-23
04035479182977PSWBIOTRONIK SE & Co. KGOSR2023-08-23
04035479179632PSWBIOTRONIK SE & Co. KGOSR2023-08-15
04035479179625NEOBIOTRONIK SE & Co. KGOSR2023-08-08
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12