Multifunctional Ablation Generator (MAG)
FDA premarket approval P200002/S005 · decided 2023-05-19
Approval details
- PMA number
- P200002
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Multifunctional Ablation Generator (MAG)
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2023-04-21
- Decision date
- 2023-05-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for labeling changes for the Multifunctional Ablation Generator (MAG).
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