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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 NameNAVISTAR RMT DS CATHETER (8MM)
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Supplement NumberS021
Date Received10/27/2010
Decision Date02/03/2011
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at biosense webster, inc, juarez, mexico.
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