Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Artic Front Advanced Cardiac Cryoablation Catheter, Artic Front Advanced 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 | S138 |
Date Received | 05/02/2023 |
Decision Date | 06/01/2023 |
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 New supplier for the Y-Block, Service Loop Top, and Service Loop Bottom components of the Arctic Front Advance and Arctic Front Advance Pro cryoablation catheters. Additionally, there are also minor updates to the molds and dimension of the components due to the new molding processes. |
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