FDA.reportPublic FDA data

CareLink SmartSync™

Primary DI
00643169957657
Brand
CareLink SmartSync™
Company
MEDTRONIC, INC.
Model
24970A
Device description
PROGRAMMER 24970A CHPBRD USA
Published
2019-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTATESTER, PACEMAKER ELECTRODE FUNCTION
DTCANALYZER, PACEMAKER GENERATOR FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTATester, Pacemaker Electrode FunctionCardiovascular2
DTCAnalyzer, Pacemaker Generator FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003386
P890003406

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003386SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ
P890003406SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169957657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169957657006431699576576431699576570643169957657

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pacemaker analyser, intraoperativeAn electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
20763000946979DLP®872202024-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33596020000External Pacemaker AnalyzerNETECH CORPORATIONDTC2024-08-23
B3359600External Pacemaker AnalyzerNETECH CORPORATIONDTC2023-07-03
00763000688400CareLink SmartSync™MEDTRONIC, INC.DTC2022-10-28
00763000688400CareLink SmartSync™MEDTRONIC, INC.DTA2022-10-28
04035479092443PK-141/2.8mBIOTRONIK SE & Co. KGDTC2021-05-06
04260451441173Osypka MedicalOsypka Medical GmbHDTA2021-04-30
00763000201289CareLink SmartSync™MEDTRONIC, INC.DTC2019-06-01
00763000201289CareLink SmartSync™MEDTRONIC, INC.DTA2019-06-01
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTA2019-04-06
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTC2019-04-06
00850540007157SigmaPace 1000FLUKE ELECTRONICS CORPORATIONDTC2018-05-24
00802526580208NABOSTON SCIENTIFIC CORPORATIONDTC2017-11-16
B3359500External Pacemaker AnanlyzerNETECH CORPORATIONDTC2017-06-16
00643169833715CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833715CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTA2017-05-25
00643169833739CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833739CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTA2017-05-25
00643169833753CareLink SmartSync™ PSA ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169868540CareLink SmartSync™MEDTRONIC, INC.DTA2017-05-25
00643169868540CareLink SmartSync™MEDTRONIC, INC.DTC2017-05-25