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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBLAZER RPM CARDIAC ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP920047
Supplement NumberS018
Date Received08/28/2002
Decision Date02/12/2003
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BLAZER RPM CATHETER WHICH FEATURED MINOR DESIGN CHANGES (E.G., ADDITION OF THREE TRANSDUCER RINGS, LASER WELDED CENTER SUPPORT AND MULTIPLE COAXIAL DESIGN) TO THE BLAZER II CATHETER.
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