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
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

Device IDPMASupp
04046955195220 P150028 000
04046955195572 P150028 000
04046955195589 P150028 000
04046955195596 P150028 000
04046955195602 P150028 000
04046955195619 P150028 000
04046955195626 P150028 000
04046955195633 P150028 000
04046955195640 P150028 000
04046955195657 P150028 000
04046955195664 P150028 000
04046955195565 P150028 000
04046955195558 P150028 000
04046955195534 P150028 000
04046955195435 P150028 000
04046955195442 P150028 000
04046955195459 P150028 000
04046955195466 P150028 000
04046955195473 P150028 000
04046955195480 P150028 000
04046955195497 P150028 000
04046955195503 P150028 000
04046955195510 P150028 000
04046955195527 P150028 000
04046955195671 P150028 000
04046955195688 P150028 000
04046964898495 P150028 000
04046964898747 P150028 000
04046964898754 P150028 000
04046964898761 P150028 000
04046964898778 P150028 000
04046964898785 P150028 000
04046964898792 P150028 000
04046964898808 P150028 000
04046964898907 P150028 000
04046964898914 P150028 000
04046964898488 P150028 000
04046955195800 P150028 000
04046955195794 P150028 000
04046955195695 P150028 000
04046955195701 P150028 000
04046955195718 P150028 000
04046955195725 P150028 000
04046955195732 P150028 000
04046955195749 P150028 000
04046955195756 P150028 000
04046955195763 P150028 000
04046955195770 P150028 000
04046955195787 P150028 000
04046964898921 P150028 000
04046955218707 P150028 000
04046955091577 P150028 000
04046955091584 P150028 000
04046955091591 P150028 000
04046955091607 P150028 000
04046955091614 P150028 000
04046955091621 P150028 000
04046955091638 P150028 000
04046955091645 P150028 000
04046955091652 P150028 000
04046955091669 P150028 000
04046955091560 P150028 000
04046955091553 P150028 000
04046955091546 P150028 000
04046955091140 P150028 000
04046955091157 P150028 000
04046955091164 P150028 000
04046955091171 P150028 000
04046955091188 P150028 000
04046955091195 P150028 000
04046955091201 P150028 000
04046955091218 P150028 000
04046955091225 P150028 000
04046955091539 P150028 000
04046955091676 P150028 000
04046955091683 P150028 000
04046955091829 P150028 000
04046955091836 P150028 000
04046955194872 P150028 000
04046955195145 P150028 000
04046955195152 P150028 000
04046955195169 P150028 000
04046955195176 P150028 000
04046955195183 P150028 000
04046955195190 P150028 000
04046955195206 P150028 000
04046955091812 P150028 000
04046955091805 P150028 000
04046955091799 P150028 000
04046955091690 P150028 000
04046955091706 P150028 000
04046955091713 P150028 000
04046955091720 P150028 000
04046955091737 P150028 000
04046955091744 P150028 000
04046955091751 P150028 000
04046955091768 P150028 000
04046955091775 P150028 000
04046955091782 P150028 000
04046955195213 P150028 000
04046964899447 P150028 000
04046964899584 P150028 000
04046964899591 P150028 000
04046964899607 P150028 000
04046964899614 P150028 000
04046964899621 P150028 000
04046964899638 P150028 000
04046964899645 P150028 000
04046964899652 P150028 000
04046964899669 P150028 000
04046964899676 P150028 000
04046964899577 P150028 000
04046964899560 P150028 000
04046964899553 P150028 000
04046964899454 P150028 000
04046964899461 P150028 000
04046964899478 P150028 000
04046964899485 P150028 000
04046964899492 P150028 000
04046964899508 P150028 000
04046964899515 P150028 000
04046964899522 P150028 000
04046964899539 P150028 000
04046964899546 P150028 000
04046955218509 P150028 000
04046955218431 P150028 000
04046955218592 P150028 000
04046955218608 P150028 000
04046955218615 P150028 000
04046955218622 P150028 000
04046955218639 P150028 000
04046955218646 P150028 000
04046955218653 P150028 000
04046955218660 P150028 000
04046955218677 P150028 000
04046955218684 P150028 000
04046955218585 P150028 000
04046955218578 P150028 000
04046955218561 P150028 000
04046955218448 P150028 000
04046955218455 P150028 000
04046955218479 P150028 000
04046955218486 P150028 000
04046955218493 P150028 000
04046955218516 P150028 000
04046955218523 P150028 000
04046955218530 P150028 000
04046955218547 P150028 000
04046955218554 P150028 000
04046955218691 P150028 000
04046964898938 P150028 000
04046964899072 P150028 000
04046964899096 P150028 000
04046964899102 P150028 000
04046964899119 P150028 000
04046964899126 P150028 000
04046964899133 P150028 000
04046964899140 P150028 000
04046964899157 P150028 000
04046964899164 P150028 000
04046964899171 P150028 000
04046964899065 P150028 000
04046964899058 P150028 000
04046964899041 P150028 000
04046964898945 P150028 000
04046964898952 P150028 000
04046964898969 P150028 000
04046964898976 P150028 000
04046964898983 P150028 000
04046964898990 P150028 000
04046964899003 P150028 000
04046964899010 P150028 000
04046964899027 P150028 000
04046964899034 P150028 000
04046964899188 P150028 000
04046964899195 P150028 000
04046964899331 P150028 000
04046964899348 P150028 000
04046964899355 P150028 000
04046964899362 P150028 000
04046964899379 P150028 000
04046964899386 P150028 000
04046964899393 P150028 000
04046964899409 P150028 000
04046964899416 P150028 000
04046964899423 P150028 000
04046964899324 P150028 000
04046964899317 P150028 000
04046964899300 P150028 000
04046964899201 P150028 000
04046964899218 P150028 000
04046964899225 P150028 000
04046964899232 P150028 000
04046964899249 P150028 000
04046964899256 P150028 000
04046964899263 P150028 000
04046964899270 P150028 000
04046964899287 P150028 000
04046964899294 P150028 000
04046964899430 P150028 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.