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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 II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP920047
Supplement NumberS058
Date Received03/25/2013
Decision Date07/22/2013
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MOVE THE EXTRUSION PROCESS FOR BLAZER PRIME ABLATIONCATHETERS TO A NEW MANUFACTURING LINE INTRODUCING AN AUTOMATED PROCESS TO IDENTIFY AND CUTMARKED SECTIONS OF THE EXTRUDED SHAFT.
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