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Device | Arctic Front Advance Pro and Arctic Front Advance Cardiac 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 | S097 |
Date Received | 09/20/2019 |
Decision Date | 10/18/2019 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Equipment and process changes for manufacturing the balloon assembly of the Arctic Front Advance and Arctic Front Advance Pro Cryoablation catheters. |