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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.
 
DeviceCELSIUS CATHETER, CELSIUS RMT CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS050
Date Received04/03/2014
Decision Date07/02/2014
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.
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