FDA.reportPublic FDA data

MyCareLink™

Primary DI
00643169657885
Brand
MyCareLink™
Company
MEDTRONIC, INC.
Model
24950J
Device description
MON 24950J MYCARELINK/SVC USA
Published
2015-12-18
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
NVZPulse generator, permanent, implantable
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003342
P890003355
P890003365
P890003380

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003342SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ
P890003355SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ
P890003365SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ
P890003380SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169657885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169657885006431696578856431696578850643169657885

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator reader, home-useAn external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. 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. This is a home-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 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
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
00802526627903LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-01-21
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
00802526625206LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2025-06-26
05415067049575Merlin™ST. JUDE MEDICAL, INC.OSR2025-06-25
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.OSR2023-05-13
00763000181185NAMEDTRONIC, INC.OSR2023-01-30
04035479179687NEOBIOTRONIK SE & Co. KGOSR2023-01-16
04035479179694PSWBIOTRONIK SE & Co. KGOSR2023-01-16
05415067040404NAST. JUDE MEDICAL, INC.OSR2023-01-09
00763000688400CareLink SmartSync™MEDTRONIC, INC.OSR2022-10-28
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.OSR2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.OSR2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.OSR2022-08-29
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000181345NAMEDTRONIC, INC.OSR2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25