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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade Name7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Date Received10/23/2002
Decision Date04/17/2003
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 05M-0475
Notice Date 11/28/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the 7f freezor cardiac cryoablation catheter and cct. 2 cryoconsole system. The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (avnrt).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S014 S015 S016 S017 S019 S021 
S022 S025 S026 S027 S028 S029 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 
S046 S047 S048 S049 S050 S051 S052 S053 S054 
S056 S058 
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