ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046/S007 · decided 2016-12-14
Approval details
- PMA number
- P100046
- Supplement
- S007
- 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
- 2016-06-22
- Decision date
- 2016-12-14
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for a manufacturing site located at 7555 Innovation Way, Mason, Ohio.
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