PMA P100046S012
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S012
- Product code
- OCM
- Decision date
- 2020-08-14
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Expand the existing manufacturing controlled room used for device packaging.
Current openFDA PMA Record#
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S012
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2020-08-14
- Decision code
- OK30
- Date received
- 2020-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand the existing manufacturing controlled room used for device packaging.