AtriCure Synergy Ablation System
FDA premarket approval P100046/S013 · decided 2022-11-15
Approval details
- PMA number
- P100046
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AtriCure Synergy Ablation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2022-03-01
- Decision date
- 2022-11-15
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for the AtriCure Multifunctional Ablation Generator (MAG) as part of the Synergy Ablation System for use with the Isolator® Synergy Clamp (OLL2 and OSL2).
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