Duns Number:006133784
Device Description: Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
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
Product Code
OCM
Product Code Name
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Public Device Record Key
0d686f4e-2595-47f8-96b7-e3994313f4a5
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |