This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | EPi-Sense® Guided Coagulation System and EPi-Sense ST™ Coagulation System |
| Generic Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Applicant | AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-09-13 |
| Decision Date | 2022-10-13 |
| PMA | P200002 |
| Supplement | S003 |
| Product Code | OCM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AtriCure, Inc. 7555 Innovation Way west Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P200002 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200002 | Original Filing | |
| S004 | 2022-09-28 | Normal 180 Day Track |
| S003 | 2022-09-13 | Normal 180 Day Track No User Fee |
| S002 | 2022-02-17 | Normal 180 Day Track |
| S001 | 2021-08-31 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 10840143901607 | P200002 | 002 |