|
Device | Arctic Front Cardiac CryoAblation Catheter and 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 | S073 |
Date Received | 02/07/2018 |
Decision Date | 04/17/2018 |
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 the implementation of a change to the product requirement specification documents related to the external surface of the effective length of the catheter, as well as associated changes to the manufacturing process and process planning matrix. |