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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 PRIME XP CARDIAC ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
PMA NumberP020025
Supplement NumberS020
Date Received04/06/2009
Decision Date10/02/2009
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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