AtriCure Synergy Ablation System
FDA premarket approval P100046/S010 · decided 2019-06-26
Approval details
- PMA number
- P100046
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AtriCure Synergy Ablation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2018-12-28
- Decision date
- 2019-06-26
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval of labeling updates to include the results of the ABLATE Post Approval Study (PAS) for the AtriCure Synergy Ablation System.
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