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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.
 
DeviceNAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990025
Supplement NumberS001
Date Received07/31/2000
Decision Date09/28/2000
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC. ,IRWINDALE, CALIFORNIA.
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