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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 NameCRYOCOR CRYOABLATION SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecardiac ablation catheter
ApplicantBOSTON SCIENTIFIC CORP.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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