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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 AND BLAZER II XP CARDIAC ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameelectrode,percutaneous,conduction tissue ablation
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS027
Date Received05/20/2005
Decision Date06/17/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the blazer ii and blazer ii xp catheters with modified mechanical performance specifications.
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