DEVICE: Micra™ (00643169529748)

Device Identifier (DI) Information

Micra™
MC1VR01US
In Commercial Distribution

MEDTRONIC, INC.
00643169529748
GS1

1
006261481 *Terms of Use
TRANSCATH PACE SYS MC1VR01US MICRA US
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60789 Intracardiac pacemaker
A battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PNJ Leadless pacemaker
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150033 000
P150033 003
P150033 051
P150033 059
P150033 077
P150033 090
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: exactly 77 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter Size 23 Fr
Length: 105.0 Centimeter
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Device Record Status

8292c61a-afcc-42c2-8a3d-a0460ea2953e
July 21, 2021
9
April 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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