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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 XP CARDIAC ABLATION CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Supplement NumberS020
Date Received04/06/2009
Decision Date10/02/2009
Product Code OAD 
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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