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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.
 
DeviceCheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
Generic NameAortic stent
ApplicantNUMED, INC.
2880 MAIN ST.
HOPKINTON, NY 12965
PMA NumberP150028
Supplement NumberS001
Date Received02/17/2017
Decision Date10/24/2017
Product Code PNF 
Docket Number 17M-6290
Notice Date 10/27/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01824160
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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