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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.
DeviceAMPLATZER Piccolo Occluder
Generic Nameoccluder, patent ductus, arteriosus
ApplicantAbbott Medical
177 county road b east
st. paul, MN 55117
PMA NumberP020024
Supplement NumberS052
Date Received08/13/2018
Decision Date01/11/2019
Product Code MAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT03055858
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AMPLATZER Piccolo Occluder.
Post-Approval StudyShow Report Schedule and Study Progress