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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.
 
DeviceSmartAblate™ Irrigation Tubing Set
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS055
Date Received06/24/2022
Decision Date01/24/2023
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for alternate components; changes in sterilization monitoring; an alternate physical manufacturing site at Harmac Medical Products, Inc. H3 de Tijuana S. de RL de CV Calle Maquiladoras No. 320-A Col. Ciudad Industrial Nueva Tijuana CP 22500 Mexico; and an alternate sterilization site at STERIS AST, 1000 Sarah Place, Ontario, CA 91761 USA.
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