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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™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”
Generic NameTranscatheter septal occluder
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS079
Date Received07/22/2024
Decision Date10/01/2024
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the addition of Centerpiece Tijuana Mexico as an alternative Ethylene Oxide (EO) sterilization facility for the sterilization of the provided devices in scope approved under the PMA/HDE numbers P000039, P02004, P200049, P120021, P040040, H070005, P190023
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