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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS008
Date Received03/01/2006
Decision Date04/19/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE STOCKERT 70 RF GENERATOR INTERFACE WITH THE COOLFLOW IRRIGATION PUMP VIA A CONNECTION CABLE.
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