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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.
 
DeviceTHERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS063
Date Received10/30/2014
Decision Date11/19/2014
Product Code LPB 
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 MINOR LABELING CHANGES.
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