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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 ABLATION 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 NumberS006
Date Received02/17/2005
Decision Date03/21/2005
Product Code DRF 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS FOR USE.
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