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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 PRIME HTD CARDIAC ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
4100 Hamline Avenue North
St Paul, MN 55112
PMA NumberP920047
Supplement NumberS039
Date Received04/06/2009
Decision Date10/02/2009
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES IN THE STEERING SUBASSEMBLY CENTER SUPPORT AND LEAF SPRINGS, DISTAL TUBING, ADDITION OF A STIFFENING ELEMENT TO THE PROXIMAL SHAFT, MINOR LABELING CHANGES, AND PACKAGING CHANGES, AND THE ADDITION OF A STERILIZATION FACILITY, STERIS ISOMEDIX CORPORATION, SOUTH PLAINFIELD, NEW JERSEY.
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