Catalog Number

LPA1200M-46

Brand Name

Tendril MRI™

Version/Model Number

LPA1200M-46

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

-

FDA Premarket Submission

P140033,P140033,P140033,P140033,P140033

Product Code

NVN

Product Code Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Public Device Record Key

e5b86fd2-fde8-4ac4-99e6-4b6af43760eb

Public Version Date

February 23, 2022

Public Version Number

7

DI Record Publish Date

February 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-