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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS036
Date Received09/22/2006
Decision Date12/21/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the steering mechanism for the n4 curve version of the blazer ii cardiac ablation catheter and steerocath-t cardiac ablation catheter and the use of a new soldering fixture in the manufacturing process.
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