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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 Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP020024
Supplement NumberS060
Date Received03/19/2020
Decision Date04/16/2020
Product Code MAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternative bacterial endotoxin testing method.
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