ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046/S008 · decided 2016-10-05
Approval details
- PMA number
- P100046
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATRICURE SYNERGY ABLATION SYSTEM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2016-09-01
- Decision date
- 2016-10-05
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Add an additional site for citric passivating the proximal jaws of the end effector on the OLL2 and OSL2 Synergy Ablation Clamps.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.