PMA P100046S004
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S004
- Product code
- OCM
- Decision date
- 2014-06-13
- Classification
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ATRICURE SYNERGY ABLATION SYSTEM
- Applicant
- AtriCure, Inc.
- PMA number
- P100046
- Supplement
- S004
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2014-06-13
- Decision code
- APPR
- Date received
- 2014-04-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.