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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.
 
DeviceVistag Surpoint External Process Unit (EPU)
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS092
Date Received10/18/2018
Decision Date04/02/2019
Product Code OAD 
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 a manufacturing site located at Flextronics, Ltd., Ramat Gavriel Industrial Zone, 2 Hamatechet St., Migdal Haemek 23108, P.O.B 867, Israel for the VISITAG SURPOINT External Processing Unit.
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