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 g-armor stent family and includes dimensional design modifications to the currently approved cp stent family
Device | G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent |
Generic Name | Aortic Stent |
Applicant | NUMED, INC. |
Date Received | 2021-09-14 |
Decision Date | 2021-12-13 |
PMA | P150028 |
Supplement | S006 |
Product Code | PNF |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | NUMED, INC. 2880 Main St. hopkinton, NY 12965 |
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 |