Approval for the mentor saline-filled testicular prosthesis. The device is indicated for use when cosmetic testicular replacement is indicated; i. E. , in the case of agenesis or following the surgical removal of a testicle.
| Device | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS |
| Classification Name | Prosthesis, Testicular |
| Generic Name | Prosthesis, Testicular |
| Applicant | COLOPLAST CORP. |
| Date Received | 2002-01-22 |
| Decision Date | 2002-07-19 |
| Notice Date | 2002-08-06 |
| PMA | P020003 |
| Supplement | S |
| Product Code | FAF |
| Docket Number | 02M-0322 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020003 | | Original Filing |
| S011 |
2022-08-17 |
30-day Notice |
| S010 |
2022-07-27 |
30-day Notice |
| S009 |
2019-09-27 |
30-day Notice |
| S008 |
2018-08-06 |
30-day Notice |
| S007 |
2010-08-18 |
Normal 180 Day Track No User Fee |
| S006 |
2008-11-24 |
30-day Notice |
| S005 |
2007-07-23 |
Normal 180 Day Track No User Fee |
| S004 |
2006-05-18 |
135 Review Track For 30-day Notice |
| S003 |
2004-07-13 |
Special (immediate Track) |
| S002 |
2004-02-17 |
30-day Notice |
| S001 |
2002-11-07 |
Normal 180 Day Track |
NIH GUDID Devices