Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL 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 | S026 |
Date Received | 03/09/2009 |
Decision Date | 07/07/2009 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW CRYOABLATION CONSOLE WHICH INCLUDES CHANGES TO THE HARDWARE, SOFTWARE, USER INTERFACE, AND MECHANICAL CIRCUIT FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CRYOCONSOLE, 7F FREEZOR XTRA SURGICAL CATHETER AND CRYOCONSOLE, AND 9F FREEZOR MAX SURGICAL CATHETER AND CRYOCONSOLE. THE NEW CRYOABLATION CONSOLE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYOCONSOLE TO BE USED WITH THE AFOREMENTIONED CATHETERS. |
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