FDA.reportPublic FDA data

Micra™

Primary DI
00643169529748
Brand
Micra™
Company
MEDTRONIC, INC.
Model
MC1VR01US
Device description
TRANSCATH PACE SYS MC1VR01US MICRA US
Published
2016-04-18
Public version status
Update
Distribution status
Not 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
P150033000
P150033003
P150033051
P150033059
P150033077
P150033090

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150033000MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMMedtronic, Inc.2016-04-06PNJ
P150033003MEDTRONIC 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169529748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169529748006431695297486431695297480643169529748

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
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

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
00643169711761Micra™MEDTRONIC, INC.PNJ2018-01-13
05414734509732Merlin.netST. JUDE MEDICAL, INC.PNJ2016-05-04
05414734509725Merlin™ST. JUDE MEDICAL, INC.PNJ2016-01-27