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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP050024
Date Received07/15/2005
Decision Date08/01/2007
Withdrawal Date 07/29/2008
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 07M-0303
Notice Date 08/03/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cryocor cryoablation system. The device is indicated for use in the ablation of isthmus-dependent right atrial flutter in patients 18 years of age or older.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001