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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.
 
DeviceBLAZER II XP/PRIME XP CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
BOSTON SCIENTIFIC
150 baytech drive
san jose, CA 95134
PMA NumberP020025
Supplement NumberS028
Date Received06/09/2011
Decision Date07/19/2011
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
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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