Catalog Number

A000435

Brand Name

Synergy™ Ablation System

Version/Model Number

ASB3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046,P100046

Product Code

OCM

Product Code Name

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Public Device Record Key

ffd3eb7c-c397-4f13-b10e-661c98dc70e8

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

30840143903018

Quantity per Package

1

Contains DI Package

10840143901584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box