PMA P100046S017
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S017
- Product code
- OCM
- Decision date
- 2023-11-22
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.
Current openFDA PMA Record#
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S017
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2023-11-22
- Decision code
- APPR
- Date received
- 2023-08-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.