FDA.reportPublic FDA data

CareLink SmartSync™ Azure Astra Application

Primary DI
00763000002039
Brand
CareLink SmartSync™ Azure Astra Application
Company
MEDTRONIC, INC.
Model
D00U003
Device description
SW D00U003 SS AZURE ASTRA
Published
2019-04-06
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
P980035536
P980035583

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980035536MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ
P980035583MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWAREMedtronic, Inc.1999-01-29NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000002039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000002039007630000020397630000020390763000002039

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac device management application softwareAn application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.

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
Lot or batch
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
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