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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.
 
DeviceCP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
Generic NameAortic stent
ApplicantNuMED, Inc.
2880 Main St.
Hopkinton, NY 12965
PMA NumberP150028
Supplement NumberS007
Date Received07/21/2025
Decision Date07/06/2026
Product Code PNF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Sterigenics U.S., LLC, 84 Park Road, Queensbury, NY 12804 as a contract sterilization facility, and modifications to reduce the ethylene oxide concentration at the existing contract sterilization facility at Cosmed Group (Lynx Medical) at 2205 East 33rd Street, Erie, PA, 16510
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