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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, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL
Generic Nameaortic stent
2880 main st.
hopkinton, NY 12965
PMA NumberP150028
Supplement NumberS004
Date Received11/26/2019
Decision Date12/19/2019
Product Code PNF 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of two laser welders.