|
Device | ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS |
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 | S031 |
Date Received | 09/11/2013 |
Decision Date | 03/19/2014 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE EQUIPMENT USED TO PERFORM IN PROCESS TESTING OF THE PRESSURE SENSOR INTEGRATED IN THE BLOOD DETECTOR BOARD, THE LEAK DETECTOR WIRE, AND THE THERMOCOUPLES AND REMOVAL OF A REDUNDANT UPSTREAM TESTING OF THE PRESSURE SENSOR FUNCTION. |