This device is indicated for use in the treatment of adult women with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
| Device | DURASPHERE INJECTABLE BULKING AGENT |
| Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. |
| Date Received | 1998-12-31 |
| Decision Date | 1999-09-13 |
| Notice Date | 1999-10-15 |
| PMA | P980053 |
| Supplement | S |
| Product Code | LNM |
| Docket Number | 99M-4278 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd. st. Paul, MN 55110-5876 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980053 | | Original Filing |
| S019 |
2022-09-27 |
30-day Notice |
| S018 |
2020-12-28 |
Normal 180 Day Track No User Fee |
| S017 |
2019-08-01 |
30-day Notice |
| S016 |
2016-03-09 |
Special (immediate Track) |
| S015 |
2013-07-22 |
30-day Notice |
| S014 |
2013-02-19 |
30-day Notice |
| S013 |
2010-12-23 |
30-day Notice |
| S012 | | |
| S011 |
2007-12-11 |
30-day Notice |
| S010 |
2006-02-23 |
30-day Notice |
| S009 |
2005-01-06 |
Normal 180 Day Track No User Fee |
| S008 |
2004-12-22 |
Normal 180 Day Track |
| S007 |
2004-06-29 |
Normal 180 Day Track |
| S006 |
2003-03-07 |
Normal 180 Day Track |
| S005 |
2002-11-29 |
Normal 180 Day Track |
| S004 |
2002-02-26 |
Normal 180 Day Track |
| S003 |
2001-03-12 |
Normal 180 Day Track |
| S002 |
2001-01-09 |
30-day Notice |
| S001 |
2000-10-06 |
30-day Notice |
NIH GUDID Devices