EPi-Sense® ST Guided Coagulation System
FDA premarket approval P200002/S002 · decided 2022-08-16
Approval details
- PMA number
- P200002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPi-Sense® ST Guided Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2022-02-17
- Decision date
- 2022-08-16
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- 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.
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