PMA P100046S003
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S003
- Product code
- OCM
- Decision date
- 2015-08-26
- 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 FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S003
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2015-08-26
- Decision code
- APPR
- Date received
- 2013-07-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION.