PMA P100046S016
- Device
- Multifunctional Ablation Generator (MAG)
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S016
- Product code
- OCM
- Decision date
- 2023-05-19
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval for labeling changes for the Multifunctional Ablation Generator (MAG).
Current openFDA PMA Record#
- Device
- Multifunctional Ablation Generator (MAG)
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S016
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2023-05-19
- Decision code
- APPR
- Date received
- 2023-04-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes for the Multifunctional Ablation Generator (MAG).