Advisa DR MRI™ SureScan® - IPG A2DR01 ADVISA DR MRI IS1 US - MEDTRONIC, INC.

Duns Number:006261481

Device Description: IPG A2DR01 ADVISA DR MRI IS1 US

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More Product Details

Catalog Number

-

Brand Name

Advisa DR MRI™ SureScan®

Version/Model Number

A2DR01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P980035,P980035,P980035

Product Code Details

Product Code

LWP

Product Code Name

Implantable pulse generator, pacemaker (non-CRT)

Device Record Status

Public Device Record Key

7bff14bf-3c21-4091-ac32-bde8936a51d0

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601