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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 NameSTOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency generator and accessories/accessory cable
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS003
Date Received10/01/2002
Decision Date10/21/2002
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the stockert 70 generator so as to deliver up to 70 watts of power when used with the navistar ds and celsius ds catheters. The stockert 70 rf generator is indicated for use in conjunction with a compatible catheter for catheter ablation procedures.
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