|
Device | ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER |
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 | S046 |
Date Received | 12/08/2014 |
Decision Date | 02/27/2015 |
Product Code |
OAE |
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 TWO NEW MODELS TO BE ADDED TO THE ARCTIC FRONT FAMILY OF CARDIAC CRYOABLATION CATHETERS: ARCTIC FRONT ADVANCE ST CARDIAC CRYOABLATION CATHETERS MODELS 2AFAST23 AND 2AFAST28. |