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 | ARCTIC FRONT CRYOBALLOON CATHETER, ARCTIC FRONT ADVANCE CRYOBALLOON 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 | S041 |
Date Received | 07/23/2014 |
Decision Date | 08/22/2014 |
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 UPDATES TO THE MANUFACTURING STEPS DURING THE HEAT SHRINK PROCESS FOR THE GUIDE WIRE LUMEN IN THE ARCTIC FRONT AND ARCTIC FRONT ADVANCE CATHETERS. |
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