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 to qualify an alternative silicone elastomer material for the macroplastique syringe stopper, as well as an alternative supplier of the syringe stopper (nusil technology, llc at carpinteria, ca. ) there is no change to the indications for use or labeling of the macroplastique device.
| Device | MACROPLASTIQUE IMPLANTS, MPQ-2.5 |
| Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | UROPLASTY, LLC |
| Date Received | 2012-10-03 |
| Decision Date | 2012-12-28 |
| PMA | P040050 |
| Supplement | S010 |
| 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 |