|
Device | Freezor Cardiac Cryoablation Catheter, 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 | S098 |
Date Received | 07/19/2021 |
Decision Date | 02/18/2022 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to expand the indication for use statement for the Freezor and Freezor Xtra Cardiac Cryoablation Catheters for use with pediatric patients. |