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® ST Guided 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 NumberS002 Date Received02/17/2022 Decision Date08/16/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-08-16 |
| PMA | P200002 |
| Supplement | S002 |
| Product Code | OCM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AtriCure, Inc. 7555 Innovation Way west Chester, OH 45040 PMA NumberP200002 Supplement NumberS002 Date Received02/17/2022 Decision Date08/16/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modified Version Of The Coagulation Probe Called EPi-Sense ST, A New Radiofrequency (RF) Cable For Use With EPi-Sense ST, And A Modified Cannula For Use With Both EPi-Sense And EPi-Sense ST |
| 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 |