PMA P100046S007
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S007
- Product code
- OCM
- Decision date
- 2016-12-14
- 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 7555 Innovation Way, Mason, Ohio.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S007
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2016-12-14
- Decision code
- APPR
- Date received
- 2016-06-22
- 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 7555 Innovation Way, Mason, Ohio.