ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046/S003 · decided 2015-08-26
Approval details
- PMA number
- P100046
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATRICURE SYNERGY ABLATION SYSTEM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2013-07-12
- Decision date
- 2015-08-26
- Days to decision
- 775 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- APPROVAL FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION.
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