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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 GENERATOR FOR CARDIAC ABLATION
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS007
Date Received04/11/2005
Decision Date07/12/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacing software version 1. 034b with version 1. 035. The device, as modified, will be marketed under the trade name stockert 70 rf generator for cardiac ablation and is indicated for use in conjunction with a compatible catheter for cardiac ablation procedures.
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