PMA P100046S008
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S008
- Product code
- OCM
- Decision date
- 2016-10-05
- Classification
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Add an additional site for citric passivating the proximal jaws of the end effector on the OLL2 and OSL2 Synergy Ablation Clamps.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S008
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2016-10-05
- Decision code
- OK30
- Date received
- 2016-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional site for citric passivating the proximal jaws of the end effector on the OLL2 and OSL2 Synergy Ablation Clamps.