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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
PMA NumberP020025
Supplement NumberS001
Date Received09/24/2003
Decision Date02/23/2004
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the blazer xp rpm catheter which combines the features of the blazer ii xp with the real time position management (rpm) tracking system technology approved for the chilli rpm catheter.