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 | Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) |
Generic Name | Aortic stent |
Applicant | NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 |
PMA Number | P150028 |
Supplement Number | S003 |
Date Received | 06/27/2018 |
Decision Date | 07/20/2018 |
Product Code |
PNF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a quality control inspection step to the Mounted CP Stent manufacturing process. |
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