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. |
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Device | G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent |
Generic Name | Aortic stent |
Applicant | NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 |
PMA Number | P150028 |
Supplement Number | S006 |
Date Received | 09/14/2021 |
Decision Date | 12/13/2021 |
Product Code |
PNF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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