Approval to add a cautionary statement to the outer packaging specifying that the device should be filled with saline prior to implantation.
| Device | SALINE-FILLED TESTICULAR PROSTHESIS |
| Classification Name | Prosthesis, Testicular |
| Generic Name | Prosthesis, Testicular |
| Applicant | COLOPLAST CORP. |
| Date Received | 2004-07-13 |
| Decision Date | 2004-07-28 |
| PMA | P020003 |
| Supplement | S003 |
| Product Code | FAF |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 |
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