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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.
 
DeviceAstron
Generic NameSTENT, ILIAC
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP140030
Supplement NumberS017
Date Received12/18/2024
Decision Date03/03/2025
Product Code NIO 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for dimensional modifications to the Luer lock connectors and manifolds as well as the corresponding injection molding equipment
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