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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 DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Supplement NumberS007
Date Received09/22/2005
Decision Date10/21/2005
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate sterilization site located at steris isomedix services, san diego, california, for the interface cables (part numbers d-1195-xx) for ablation catheters.
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