Synergy Ablation System
FDA premarket approval P100046/S012 · decided 2020-08-14
Approval details
- PMA number
- P100046
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Synergy Ablation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2020-08-03
- Decision date
- 2020-08-14
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Expand the existing manufacturing controlled room used for device packaging.
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