GUDID 00681490501880

SFTWR 9790XLA LEAD PATIENT LONG 9790 TAC

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00681490501880
NIH Device Record Key8ad4368e-a2f0-488d-b3c6-fa6e0b4a2163
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number9790XLA
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490501880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-18
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00199150000296 - NA2025-03-14 CUSTOM PACK BB10R33R2 WHLG SUPT
00199150000302 - NA2025-03-14 CUSTOM PACK BB12D68R1 1/4 DAV PK
20199150000320 - NA2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP
20199150000344 - NA2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB
20199150000368 - NA2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB
00199150000616 - NA2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS
00199150000623 - NA2025-03-14 CUSTOM PACK BB7E57R18 PUMP
00199150000630 - NA2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.