ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046/S006 · decided 2015-02-12
Approval details
- PMA number
- P100046
- Supplement
- S006
- Supplement type
- Real-Time Process
- 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
- 2014-11-21
- Decision date
- 2015-02-12
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- APPROVAL FOR UPDATING THE TRANSFORMER IN THE ASU GENERATOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.