Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAtriCure Synergy Ablation System
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantAtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
PMA NumberP100046
Supplement NumberS013
Date Received03/01/2022
Decision Date11/15/2022
Product Code OCM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the AtriCure Multifunctional Ablation Generator (MAG) as part of the Synergy Ablation System for use with the Isolator® Synergy Clamp™ (OLL2 and OSL2).
-
-