PMA P200002S002

Device: EPi-Sense® ST Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S002
Product code: OCM
Decision date: 2022-08-16
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: Approval for 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.

Current openFDA PMA Record#

Device: EPi-Sense® ST Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S002
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2022-08-16
Decision code: APPR
Date received: 2022-02-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 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.