|
Device | 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S007 |
Date Received | 02/14/2005 |
Decision Date | 03/29/2005 |
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 A MODIFICATION FROM TEMPERATURE TO FLOW CONTROL IN CRYOABLATION MODE OF THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE. |