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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 Rd. B E.
St.Paul, MN 55117
PMA NumberP020024
Supplement NumberS062
Date Received04/15/2020
Decision Date07/09/2020
Product Code MAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT04371081
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the Amplatzer Piccolo occluder Instructions for Use (IFU).
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