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.
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.
Device | Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) |
Classification Name | Aortic Stent |
Generic Name | Aortic Stent |
Applicant | NUMED, INC. |
Date Received | 2017-02-17 |
Decision Date | 2017-10-24 |
Notice Date | 2017-10-27 |
PMA | P150028 |
Supplement | S001 |
Product Code | PNF |
Docket Number | 17M-6290 |
Advisory Committee | Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
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 |
Supplement Number | Date | Supplement Type |
---|---|---|
P150028 | Original 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 |