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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
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
Abbott Medical
5050 nathan lane north
plymouth, MN 55442
PMA NumberP020024
Supplement NumberS052
Date Received08/13/2018
Decision Date01/11/2019
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Clinical Trials NCT03055858
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 AMPLATZER Piccolo Occluder.
Post-Approval StudyShow Report Schedule and Study Progress
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