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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)
Classification Nameaortic stent
Generic Nameaortic stent
Applicant
NUMED, INC.
2880 main st.
hopkinton, NY 12965
PMA NumberP150028
Supplement NumberS001
Date Received02/17/2017
Decision Date10/24/2017
Product Code
PNF[ Registered Establishments with PNF ]
Docket Number 17M-6290
Notice Date 10/27/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01824160
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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