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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.
 
DeviceCoolFlow Irrigation Tubing Set
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS040
Date Received06/20/2018
Decision Date05/08/2019
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the addition of a second source supplier for the CoolFlow Irrigation Tubing Set, which is a manufacturing site located at: Lake Region Medical, Inc.Venusa de Mexico S. de R.L. de C.V.1525 Calle Hertz Street Parque Industrial Antonio J. BermudezCiudad Juarez, Chihuahua 32470 Mexico
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