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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.
 
DeviceTHE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
Generic NameTranscatheter septal occluder
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS054
Date Received03/14/2016
Decision Date04/12/2016
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
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