CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Aortic Stent

FDA Premarket Approval P150028

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.

Pre-market Approval Supplement Details

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.

DeviceCHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
Classification NameAortic Stent
Generic NameAortic Stent
ApplicantNUMED, INC.
Date Received2015-08-05
Decision Date2016-03-25
Notice Date2016-04-12
PMAP150028
SupplementS
Product CodePNF
Docket Number16M-1122
Advisory CommitteeCardiovascular
Expedited ReviewYes
Combination Product No
Applicant Address NUMED, INC. 2880 Main St. hopkinton, NY 12965
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150028Original Filing
S006 2021-09-14 Normal 180 Day Track
S005 2021-04-28 Real-time Process
S004 2019-11-26 30-day Notice
S003 2018-06-27 Special (immediate Track)
S002 2018-03-07 Normal 180 Day Track
S001 2017-02-17 Panel Track

NIH GUDID Devices

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