|
Device | 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S108 |
Date Received | 12/11/2023 |
Decision Date | 01/08/2024 |
Product Code |
LPB |
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 a new mold for the rear strain relief component used in manufacturing Arctic Front Advance and Arctic Front Advance Pro and the rear strain relief proximal component used in manufacturing Freezer, Freezer Xtra, and Freezer MAX |