ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
FDA premarket approval P100046/S002 · decided 2013-06-14
Approval details
- PMA number
- P100046
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2013-05-13
- Decision date
- 2013-06-14
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- ADDITION OF A VISUAL INSPECTION FOR PROXIMAL WELD LENGTH FOR THE DEVICES, MODIFICATIONS RELATING TO THE LASER WELDER FOR DISTAL AND PROXIMAL JAW WELDMENTS AND THE ADDITION OF A RE-WELDING PROCESS FOR THE OLL2 AND OSL2 PROXIMAL AND DISTAL WELDMENTS.
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