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Synergy™ Ablation System

FDA UDI

Class III (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
Synergy™ Ablation System FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve FDA UDI
Model / Reference
OLL2 FDA UDI
Description
Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve FDA UDI

Identifiers

Catalog Number
A000362 FDA UDI
Primary DI / UDI-DI
10840143902109 FDA UDI
PMA Number
P100046 FDA UDI
FDA Product Code
OCM FDA UDI
GMDN Term
Cardiac radio-frequency ablation system generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac radio-frequency ablation system generator

Synergy™ Ablation System by Atricure, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac radio-frequency ablation system generator.

Cleared under the same submission

P100046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI b3e1a8b7-992e-45c0-b635-c311d7690d1c 36 fields · synced May 30, 2026