ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046/S005 · decided 2014-10-22
Approval details
- PMA number
- P100046
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATRICURE SYNERGY ABLATION SYSTEM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2014-05-21
- Decision date
- 2014-10-22
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, MILPITAS, CALIFORNIA.
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