Synergy Ablation System
FDA premarket approval P100046/S017 · decided 2023-11-22
Approval details
- PMA number
- P100046
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Synergy Ablation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2023-08-31
- Decision date
- 2023-11-22
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.
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