|
Device | 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S006 |
Date Received | 05/10/2004 |
Decision Date | 10/26/2004 |
Product Code |
LPB |
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 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE, A MODIFICATION TO THE FREEZOR XTRA CARDIAC CRYOABLATION SYSTEM PREVIOUSLY APPROVED UNDER P020045/S005. THE DEVICE IS INDICATED FOR MINIMALLY INVASIVE CARDIAC SURGERY PROCEDURES, INCLUDING SURGICAL TREATMENT OF CARDIAC ARRHYTHMIAS. |