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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBLAZER II/PRIME HTD CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS047
Date Received06/09/2011
Decision Date07/19/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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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