FDA.reportPublic FDA data

Micra™

Primary DI
00643169711761
Brand
Micra™
Company
MEDTRONIC, INC.
Model
MC1VR01US
Device description
TPS MC1VR01US MICRA US SCALABLE
Published
2018-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNJLeadless pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNJLeadless PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150033015
P150033051
P150033059
P150033077
P150033090
P150033212
P150033217

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150033015MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033051MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033059MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033077MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033090MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033212MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033217MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169711761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169711761006431697117616431697117610643169711761

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac pacemakerA sterile, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length105Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 Degrees Fahrenheit

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
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067051189AVEIR™ST. JUDE MEDICAL, INC.PNJ2025-08-07
05415067050045Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.PNJ2025-02-11
05415067049971AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-12
05415067046468AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
05415067046475AVEIR™ST. JUDE MEDICAL, INC.PNJ2024-12-11
05415067040701Aveir™ST. JUDE MEDICAL, INC.PNJ2023-09-12
05415067040725Aveir™ST. JUDE MEDICAL, INC.PNJ2023-09-12
05415067038487Aveir™ST. JUDE MEDICAL, INC.PNJ2023-08-15
00763000078645Micra™ AV2MEDTRONIC, INC.PNJ2023-05-05
00763000078683Micra™ VR2MEDTRONIC, INC.PNJ2023-05-05
05415067031914Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067034472Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
05415067036384Aveir™ST. JUDE MEDICAL, INC.PNJ2023-03-03
00763000078621Micra™ AVMEDTRONIC, INC.PNJ2020-02-02
05414734509732Merlin.netST. JUDE MEDICAL, INC.PNJ2016-05-04
00643169529748Micra™MEDTRONIC, INC.PNJ2016-04-18
05414734509725Merlin™ST. JUDE MEDICAL, INC.PNJ2016-01-27