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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 RADIOFREQUENCY ABLATION GENERATOR
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency generator and accessories/accessory cable
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS006
Date Received02/17/2005
Decision Date03/21/2005
Product Code
DRF[ Registered Establishments with DRF ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes that strengthen the instructions for use.
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