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.
Approval for macroplastique implants. The device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (sui) primarily due to intrinsic sphincter deficiency (isd).
| 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 | 2004-12-22 |
| Decision Date | 2006-10-30 |
| Notice Date | 2006-11-08 |
| PMA | P040050 |
| Supplement | S |
| Product Code | LNM |
| Docket Number | 06M-0457 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UROPLASTY, LLC 5420 Feltl Road minnetonka, MN 55343 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |