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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received08/05/2015
Decision Date03/25/2016
Product Code
PNF[ Registered Establishments with PNF ]
Docket Number 16M-1122
Notice Date 04/12/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00552812
NCT01278303
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the Cheatham Platinum (CP) Stent System, including the CP Stent, Mounted CP Stent, Covered CP Stent, and Covered Mounted CP Stent. The CP Stent and Mounted CP Stent are indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective.The Covered CP Stent and Covered Mounted CP Stent are indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery associated with one or more of the following: Acute or chronic aortic wall injury; Nearly atretic descending aorta of 3 mm or less in diameter; A non-compliant stenotic aortic segment found on pre-stent balloon dilation; A genetic or congenital syndrome associated with aortic wall weakening or ascending aortic aneurysm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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