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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.
 
DeviceNuDEL Delivery System
Generic NameAortic stent
ApplicantNuMED, Inc.
2880 Main St.
Hopkinton, NY 12965
PMA NumberP150028
Supplement NumberS005
Date Received04/28/2021
Decision Date07/28/2021
Product Code PNF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to extend the packaging shelf life of the NuDEL Delivery System.
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