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 |
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PMA Number | P150028 |
Supplement Number | S001 |
Date Received | 02/17/2017 |
Decision Date | 10/24/2017 |
Product Code |
PNF
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Docket Number | 17M-6290 |
Notice Date | 10/27/2017 |
Advisory Committee |
Cardiovascular |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
Approval for the Covered CP Stent and Covered Mounted CP Stent Models. This device is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract, RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). In addition, approval for additional sizes (10-zig and lengths up to 60 mm for 8- and 10-zig configurations) for the Cheatham Platinum Stent System. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
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