|
Device | Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance PRO 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 | S139 |
Date Received | 05/24/2023 |
Decision Date | 08/21/2023 |
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 a design modification to materials used in the lumen of the Arctic Front Advance Cardiac Cryoablation Catheter and the Arctic Front Advance PRO Cardiac Cryoablation Catheter. |