FDA.reportPublic FDA data

CareLink SmartSync™

Primary DI
00763000201289
Brand
CareLink SmartSync™
Company
MEDTRONIC, INC.
Model
24970A
Device description
PROGRAMMER 24970A US MKT BASE ONLY
Published
2019-06-01
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
00763000201289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000201289007630002012897630002012890763000201289

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
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02

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
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTA2019-04-06
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTC2019-04-06
00643169957657CareLink SmartSync™MEDTRONIC, INC.DTC2019-03-30
00643169957657CareLink SmartSync™MEDTRONIC, INC.DTA2019-03-30
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