Micra™ AV

GUDID 00763000078621

TPS MC1AVR1 MICRA AV US H3

MEDTRONIC, INC.

Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker
Primary Device ID00763000078621
NIH Device Record Keybd638e57-9650-4d9a-b7c5-71a762e850ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicra™ AV
Version Model NumberMC1AVR1
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
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Length105 Centimeter
Device Size Text, specify0
Length105 Centimeter
Device Size Text, specify0
Length105 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000078621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNJLeadless pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-02-02

Devices Manufactured by MEDTRONIC, INC.

00763000944322 - NA2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
00763000944339 - NA2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
00763000944346 - NA2024-04-23 CUSTOM PACK BB12F35R5 A PACK
00763000945558 - NA2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
00763000943844 - NA2024-04-12 CUSTOM PACK BB11J59R5 PEDS
00763000943851 - NA2024-04-12 CUSTOM PACK BB12F35R3 A PACK
00763000943868 - NA2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
00763000943899 - NA2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD

Trademark Results [Micra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MICRA
MICRA
86794383 not registered Live/Pending
Nissan Jidosha Kabushiki Kaisha
2015-10-21
MICRA
MICRA
85715767 4568896 Live/Registered
Medtronic, Inc.
2012-08-29
MICRA
MICRA
85646130 4584996 Live/Registered
Medtronic, Inc.
2012-06-07
MICRA
MICRA
85373179 not registered Dead/Abandoned
Shiela Nail Products, Inc.
2011-07-16
MICRA
MICRA
85373179 not registered Dead/Abandoned
J-mar International
2011-07-16
MICRA
MICRA
79048392 3492995 Dead/Cancelled
CONTROLLI S.P.A.
2007-12-20
MICRA
MICRA
78363412 not registered Dead/Abandoned
Microeconomic Consulting & Research Associates, Inc.
2004-02-05
MICRA
MICRA
77577332 3688412 Dead/Cancelled
Nissan Jidosha Kabushiki Kaisha
2008-09-24
MICRA
MICRA
76438044 2715711 Dead/Cancelled
KIDDE PRODUCTS LIMITED
2002-08-05
MICRA
MICRA
76303416 2741079 Dead/Cancelled
Montegrappa 1912 S.p.A.
2001-08-22
MICRA
MICRA
75871337 2622792 Dead/Cancelled
NISSAN JIDOSHA KABUSHIKI KAISHA
1999-12-14
MICRA
MICRA
75639758 not registered Dead/Abandoned
NISSAN JIDOSHA KABUSHIKI KAISHA
1999-02-11

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