PMA P100046S010
- Device
- AtriCure Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S010
- Product code
- OCM
- Decision date
- 2019-06-26
- Classification
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval of labeling updates to include the results of the ABLATE Post Approval Study (PAS) for the AtriCure Synergy Ablation System.
Current openFDA PMA Record#
- Device
- AtriCure Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S010
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2019-06-26
- Decision code
- APPR
- Date received
- 2018-12-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of labeling updates to include the results of the ABLATE Post Approval Study (PAS) for the AtriCure Synergy Ablation System.