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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.
 
DeviceG-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent
Generic NameAortic stent
ApplicantNuMED, Inc.
2880 Main St.
Hopkinton, NY 12965
PMA NumberP150028
Supplement NumberS006
Date Received09/14/2021
Decision Date12/13/2021
Product Code PNF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the G-Armor Stent Family and includes dimensional design modifications to the currently approved CP Stent Family.
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