PMA P100046S011
- Device
- AtriCure Synergy Ablation System
- Applicant
- AtriCure, Inc.
- Product code
- OCM
- Decision date
- 2020-11-20
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval for the use of an alternate ABS resin material for the OSL2, OLL2 clamp.
Current openFDA PMA Record#
- Device
- AtriCure Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S011
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2020-11-20
- Decision code
- APPR
- Date received
- 2019-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of an alternate ABS resin material for the OSL2, OLL2 clamp.