PMA P100046S005
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S005
- Product code
- OCM
- Decision date
- 2014-10-22
- 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 MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, MILPITAS, CALIFORNIA.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S005
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2014-10-22
- Decision code
- APPR
- Date received
- 2014-05-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, MILPITAS, CALIFORNIA.