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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
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 
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 AMPLATZER Piccolo Occluder.
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