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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 CATHETHER, STEEROCATH-A CARDIAC ABLATION CATHETER,STEEROCATH-T CARDIAC ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Nameelectrode,percutaneous,conduction tissue ablation
ApplicantBOSTON SCIENTIFIC EP TECHNOLOGIES
PMA NumberP920047
Supplement NumberS021
Date Received11/03/2003
Decision Date12/31/2003
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization facility located at cosmed of rhode island, inc. , coventry, rhode island.
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