Catalog Number

A000362

Brand Name

Synergy™ Ablation System

Version/Model Number

OLL2

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

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

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,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

b3e1a8b7-992e-45c0-b635-c311d7690d1c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 08, 2021

Package DI Number

30840143902141

Quantity per Package

1

Contains DI Package

10840143902109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box