Synergy Ablation System
FDA premarket approval P100046/S009 · decided 2018-12-31
Approval details
- PMA number
- P100046
- Supplement
- S009
- 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
- 2018-12-10
- Decision date
- 2018-12-31
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Expand Atricures current manufacturing site to include an additional building located within close proximity to the current manufacturing facility (within 0.3 miles) to conduct distribution, warehousing, and servicing operations currently conducted in the current facility footprint.
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