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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/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS033
Date Received03/01/2011
Decision Date02/08/2012
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 AN INCREASE IN THE NUMBER OF ALLOWED ETO STERILIZATION CYCLES, AND A MODIFICATION TO THE WORKMANSHIP INSPECTION PERFORMED BY QUALITY CONTROL.
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