|
Device | ARCTIC FRONT CRYOCATHETER SYSTEM |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MS MVS46 MOUNDS VIEW, MN 55112 |
PMA Number | P100010 |
Supplement Number | S060 |
Date Received | 11/14/2016 |
Decision Date | 01/17/2017 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for replacement of the operating system within the CryoConsole from Windows XP Embedded (WinXPE) to the Windows Embedded Standard 2009 (WES2009). |