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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
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS004
Date Received11/05/2003
Decision Date02/24/2004
Product Code DRF 
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 ADDITION OF A STOCKERT REMOTE CONTROL AND CONNECTION CABLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT REMOTE CONTROL AND CONNECTION CABLE AND IS INDICATED FOR USE IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO BE USED IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
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