Approval for a modified bead specification (90-212 um) for the pyrolytic carbon coated zirconium oxide and graphite beads. The device, as modified, will be marketed under the trade name durasphere exp and is indicated for use in the treatment of adult women with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
| Device | DURASPHERE EXP |
| 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 | 2003-03-07 |
| Decision Date | 2003-08-26 |
| PMA | P980053 |
| Supplement | S006 |
| 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 | CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd. st. Paul, MN 55110-5876 |
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