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 a modified formulation of the polymer resin used in the syringe barrel.
| Device | Macroplastique Implants |
| Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | UROPLASTY, LLC |
| Date Received | 2019-04-17 |
| Decision Date | 2019-07-15 |
| PMA | P040050 |
| Supplement | S012 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UROPLASTY, LLC 5420 Feltl Road minnetonka, MN 55343 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040050 | Original Filing | |
| S012 | 2019-04-17 | Normal 180 Day Track |
| S011 | 2014-08-19 | 30-day Notice |
| S010 | 2012-10-03 | Normal 180 Day Track |
| S009 | ||
| S008 | 2011-05-02 | 30-day Notice |
| S007 | 2010-11-24 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2010-06-03 | 30-day Notice |
| S004 | 2009-10-23 | 30-day Notice |
| S003 | 2009-02-18 | Normal 180 Day Track No User Fee |
| S002 | 2007-08-22 | Normal 180 Day Track No User Fee |
| S001 | 2007-03-02 | Normal 180 Day Track No User Fee |