|
Device | 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 | S134 |
Date Received | 12/21/2022 |
Decision Date | 01/19/2023 |
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 Implementation of an alternative to the batch endotoxin monitoring program at the Montreal Medtronic Operations (MMO) manufacturing site in Canada. |