AtriCure Synergy Ablation System

FDA PMAFDA UDIFDA 510(k)

Class III (US FDA PMA)

PMA P100046510(k) K063630

by Atricure, Inc.

Identity

Trade Name: ATRICURE SYNERGY ABLATION SYSTEM FDA PMA
Synergy™ Ablation System FDA UDI
Generic Name: Surgical cardiac ablation device, for treatment of atrial fibrillation FDA PMA
Electrosurgical cable adaptor FDA UDI
Device Name: AtriCure Switch Box FDA UDI
Model / Reference: ASB3 FDA UDI
Description: AtriCure Switch Box FDA UDI

Identifiers

Catalog Number: A000435 FDA UDI
Primary DI / UDI-DI: 10840143901584 FDA UDI
PMA Number: P100046 FDA PMAFDA UDI
510(k) Number: K063630 FDA PMA
FDA Product Code: GEI FDA PMA
OCM FDA UDI
GMDN Term: Electrosurgical cable adaptor FDA UDI

Classification

Device Class: Class II FDA PMA
Class III FDA UDI
Legislation / Framework: 21 CFR Part 878.4400 FDA PMA
Regulation Number: 878.4400 FDA PMA
Advisory Committee: General, Plastic Surgery FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The AtriCure Synergy Ablation System is a surgical cardiac ablation device designed for the treatment of atrial fibrillation. It is indicated for the ablation of cardiac tissue in patients with persistent atrial fibrillation or longstanding persistent atrial fibrillation.

This system is intended for use in patients undergoing open concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. The device is authorized for clinical use under FDA 510(k) and PMA regulatory pathways.

Frequently asked questions

What is the primary use of the AtriCure Synergy Ablation System?

The system is used for the ablation of cardiac tissue to treat persistent or longstanding persistent atrial fibrillation in patients undergoing specific open-heart surgical procedures.

Which patients are candidates for this ablation system?

Candidates include patients diagnosed with persistent atrial fibrillation or longstanding persistent atrial fibrillation who are already undergoing open concomitant coronary artery bypass grafting or valve replacement and repair.

Is the AtriCure Synergy Ablation System FDA authorized?

Yes, the device has received regulatory authorization through both FDA 510(k) and PMA pathways, confirming it meets the necessary requirements for its indicated use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Isolator Synergy Clamps (OLL2/OSL2) - AtriCure, Isolator Synergy EnCompass Clamp | Ablation Therapy - AtriCure, Isolator Synergy Access Clamp | Bipolar System - AtriCure, AtriCure Launches EnCompass® Clamp, a part of Isolator ..., Isolator Synergy EnCompass Clamp - YouTube

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K063630	Class III	Active
FDA PMA	United States	FDA_PMA	P100046	Class III	Active

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Manufacturer

Manufacturer: Atricure, Inc.

Sources (3)

FDA PMA P100046 37 fields · synced Sep 18, 2026
FDA UDI ffd3eb7c-c397-4f13-b10e-661c98dc70e8 37 fields · synced May 26, 2026
FDA 510(k) K063630 1 fields · synced May 18, 2026