PMA P100046S009
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S009
- Product code
- OCM
- Decision date
- 2018-12-31
- Classification
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Expand Atricures current manufacturing site to include an additional building located within close proximity to the current manufacturing facility (within 0.3 miles) to conduct distribution, warehousing, and servicing operations currently conducted in the current facility footprint.
Current openFDA PMA Record#
- Device
- Synergy Ablation System
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S009
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2018-12-31
- Decision code
- OK30
- Date received
- 2018-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand Atricures current manufacturing site to include an additional building located within close proximity to the current manufacturing facility (within 0.3 miles) to conduct distribution, warehousing, and servicing operations currently conducted in the current facility footprint.