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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/PRIME HTD CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP920047
Supplement NumberS047
Date Received06/09/2011
Decision Date07/19/2011
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
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