PMA P100046S002
- Device
- ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S002
- Product code
- OCM
- Decision date
- 2013-06-14
- Classification
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- ADDITION OF A VISUAL INSPECTION FOR PROXIMAL WELD LENGTH FOR THE DEVICES, MODIFICATIONS RELATING TO THE LASER WELDER FOR DISTAL AND PROXIMAL JAW WELDMENTS AND THE ADDITION OF A RE-WELDING PROCESS FOR THE OLL2 AND OSL2 PROXIMAL AND DISTAL WELDMENTS.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S002
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2013-06-14
- Decision code
- OK30
- Date received
- 2013-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A VISUAL INSPECTION FOR PROXIMAL WELD LENGTH FOR THE DEVICES, MODIFICATIONS RELATING TO THE LASER WELDER FOR DISTAL AND PROXIMAL JAW WELDMENTS AND THE ADDITION OF A RE-WELDING PROCESS FOR THE OLL2 AND OSL2 PROXIMAL AND DISTAL WELDMENTS.