PMA P100046S019
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S019
- Product code
- OCM
- Decision date
- 2025-06-17
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- an additional contract sterilizer and a process change to the ethylene oxide sterilization method
Current openFDA PMA Record#
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S019
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2025-06-17
- Decision code
- APPR
- Date received
- 2025-03-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional contract sterilizer and a process change to the ethylene oxide sterilization method