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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.
 
DeviceVisitag Surpoint External Processing Unit (EPU)
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
BIOSENSE WEBSTER, INC.
33 technology drive
irvine, CA 92618
PMA NumberP030031
Supplement NumberS086
Date Received12/04/2017
Decision Date06/01/2018
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the VISITAG SURPOINT External Processing Unit.
Post-Approval StudyShow Report Schedule and Study Progress
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