|
Device | ATRICURE SYNERGY ABLATION SYSTEM |
Generic Name | Surgical cardiac ablation device, for treatment of atrial fibrillation |
Applicant | ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
PMA Number | P100046 |
Supplement Number | S003 |
Date Received | 07/12/2013 |
Decision Date | 08/26/2015 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION. |