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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 FLTR CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP010068
Supplement NumberS037
Date Received10/18/2013
Decision Date11/26/2013
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.
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