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 | CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL |
Generic Name | Aortic stent |
Applicant | NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 |
PMA Number | P150028 |
Supplement Number | S004 |
Date Received | 11/26/2019 |
Decision Date | 12/19/2019 |
Product Code |
PNF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-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. |
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