Product code OCM
- Device name
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Surgical cardiac ablation for the treatment of atrial fibrillation.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P200002S014 | EPi-Sense and EPi-Sense ST Guided Coagulation System | AtriCure, Inc. | 2026-05-06 |
| P100046S020 | Synergy Ablation System | AtriCure, Inc. | 2026-05-06 |
| P200002S013 | EPi-Sense ST Coagulation System | AtriCure, Inc. | 2025-11-14 |
| P200002S012 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | 2025-10-07 |
| P200002S011 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | 2025-06-17 |
| P100046S019 | Synergy Ablation System | AtriCure, Inc. | 2025-06-17 |
| P200002S010 | EPi-Sense and EPi-Sense ST Guided Coagulation System | AtriCure, Inc. | 2025-03-03 |
| P200002S009 | Cannula with Guide | AtriCure, Inc. | 2024-08-28 |
| P100046S018 | Synergy Ablation System | AtriCure, Inc. | 2024-03-15 |
| P200002S008 | EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System | AtriCure, Inc. | 2023-12-11 |
| P200002S007 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | 2023-11-22 |
| P100046S017 | Synergy Ablation System | AtriCure, Inc. | 2023-11-22 |
| P200002S006 | EPi-Sense ST RF Cable | AtriCure, Inc. | 2023-05-25 |
| P200002S005 | Multifunctional Ablation Generator (MAG) | AtriCure, Inc. | 2023-05-19 |
| P100046S016 | Multifunctional Ablation Generator (MAG) | AtriCure, Inc. | 2023-05-19 |
| P100046S015 | AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp | AtriCure, Inc. | 2023-03-23 |
| P200002S004 | EPi-Sense®, EPi-Sense ST™ Guided Coagulation System | AtriCure, Inc. | 2022-12-27 |
| P100046S013 | AtriCure Synergy Ablation System | AtriCure, Inc. | 2022-11-15 |
| P200002S003 | EPi-Sense® Guided Coagulation System and EPi-Sense ST™ Coagulation System | AtriCure, Inc. | 2022-10-13 |
| P200002S002 | EPi-Sense® ST Guided Coagulation System | AtriCure, Inc. | 2022-08-16 |
| P200002S001 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | 2022-01-10 |
| P200002 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | 2021-04-28 |
| P100046S011 | AtriCure Synergy Ablation System | AtriCure, Inc. | 2020-11-20 |
| P100046S012 | Synergy Ablation System | AtriCure, Inc. | 2020-08-14 |
| P100046S010 | AtriCure Synergy Ablation System | AtriCure, Inc. | 2019-06-26 |
| P100046S009 | Synergy Ablation System | AtriCure, Inc. | 2018-12-31 |
| P100046S007 | ATRICURE SYNERGY ABLATION SYSTEM | AtriCure, Inc. | 2016-12-14 |
| P100046S008 | ATRICURE SYNERGY ABLATION SYSTEM | AtriCure, Inc. | 2016-10-05 |
| P100046S003 | ATRICURE SYNERGY ABLATION SYSTEM | AtriCure, Inc. | 2015-08-26 |
| P100046S006 | ATRICURE SYNERGY ABLATION SYSTEM | AtriCure, Inc. | 2015-02-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30840143913703 | Multifunctional Ablation Generator | ATRICURE, INC. | 2026-05-27 |
| 10840143913761 | Isolator Synergy™ | ATRICURE, INC. | 2026-05-12 |
| 10840143913884 | EPi-Sense ST | ATRICURE, INC. | 2026-04-23 |
| 10840143913273 | EPi-Sense ST | ATRICURE, INC. | 2026-04-23 |
| 10840143909382 | EPi-Sense ST Guided Coagulation System | ATRICURE, INC. | 2026-04-23 |
| 10840143909375 | EPi-Sense Guided Coagulation System | ATRICURE, INC. | 2026-04-23 |
| 10840143907852 | Cannula with Guide | ATRICURE, INC. | 2026-04-23 |
| 10840143907845 | Subtle Cannula with Guide | ATRICURE, INC. | 2026-04-23 |
| 10840143907807 | EPi-Sense Guided Coagulation System | ATRICURE, INC. | 2026-04-23 |
| 30840143902950 | Isolator Surgical Ablation System | ATRICURE, INC. | 2026-02-06 |
| 10840143901553 | Isolator Surgical Ablation System | ATRICURE, INC. | 2026-02-06 |
| 30840143904473 | Multifunctional Ablation Generator | ATRICURE, INC. | 2023-02-21 |
| 10840143900044 | Multifunctional Ablation Generator | ATRICURE, INC. | 2023-02-21 |
| 30840143901663 | Coagulation RF cable | ATRICURE, INC. | 2022-09-23 |
| 10840143901607 | Cannula with Guide | ATRICURE, INC. | 2022-09-23 |
| 30840143901656 | EPi-Sense ST Coagulation Device | ATRICURE, INC. | 2022-09-23 |
| 10840143901485 | Coagulation RF cable | ATRICURE, INC. | 2022-09-23 |
| 10840143904585 | EPi-Sense ST Coagulation Device | ATRICURE, INC. | 2022-09-23 |
| 10840143904578 | nContact RF Generator | ATRICURE, INC. | 2021-05-24 |
| 10840143904547 | Subtle Cannula with Guide | ATRICURE, INC. | 2021-05-24 |
| 10840143904530 | Coagulation RF Cable | ATRICURE, INC. | 2021-05-24 |
| 30840143903803 | Coagulation RF Cable | ATRICURE, INC. | 2021-05-24 |
| 30840143903810 | Subtle Cannula with Guide | ATRICURE, INC. | 2021-05-24 |
| 10840143904554 | EPi-Sense Guided Coagulation System with VisiTrax | ATRICURE, INC. | 2021-05-24 |
| 10840143904561 | nContact RF Generator | ATRICURE, INC. | 2021-05-24 |
| 30840143902134 | nContact RF Generator | ATRICURE, INC. | 2021-05-24 |
| 10840143901584 | Synergy™ Ablation System | ATRICURE, INC. | 2021-01-11 |
| 30840143903018 | Synergy™ Ablation System | ATRICURE, INC. | 2021-01-11 |
| 10840143902192 | Synergy™ Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902109 | Synergy™ Ablation System | ATRICURE, INC. | 2021-01-08 |