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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 Muscular VSD Occluder
Generic NameTranscatheter septal occluder
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP040040
Supplement NumberS041
Date Received04/06/2020
Decision Date10/06/2020
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a process change in the manufacture of the polyester used in the AMPLATZER device family.
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