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. |
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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 |
Date Received | 08/05/2015 |
Decision Date | 03/25/2016 |
Product Code |
PNF |
Docket Number | 16M-1122 |
Notice Date | 04/12/2016 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00552812
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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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 |
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