AtriCure Synergy Ablation System
FDA premarket approval P100046/S011 · decided 2020-11-20
Approval details
- PMA number
- P100046
- Supplement
- S011
- 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
- 2019-07-02
- Decision date
- 2020-11-20
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for the use of an alternate ABS resin material for the OSL2, OLL2 clamp.
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