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 the mentor alpha i inflatable penile prosthesis. This device is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
| Device | TITAN INFLATABLE PENILE PROSTHESIS |
| Classification Name | Device, Impotence, Mechanical/hydraulic |
| Generic Name | Device, Impotence, Mechanical/hydraulic |
| Applicant | COLOPLAST CORP. |
| Date Received | 2000-01-18 |
| Decision Date | 2000-07-14 |
| Notice Date | 2000-07-25 |
| PMA | P000006 |
| Supplement | S |
| Product Code | FHW |
| Docket Number | 00M-1415 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 |
| 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 |
|---|---|---|
| P000006 | Original Filing | |
| S065 | 2022-12-16 | 30-day Notice |
| S064 | ||
| S063 | 2022-11-02 | 30-day Notice |
| S062 | 2022-07-27 | 30-day Notice |
| S061 | 2022-03-16 | 30-day Notice |
| S060 | 2021-11-26 | 30-day Notice |
| S059 | 2020-12-09 | 30-day Notice |
| S058 | 2020-09-08 | Real-time Process |
| S057 | 2020-09-01 | 30-day Notice |
| S056 | 2020-05-08 | 30-day Notice |
| S055 | ||
| S054 | ||
| S053 | 2019-09-27 | 30-day Notice |
| S052 | 2019-07-22 | 30-day Notice |
| S051 | ||
| S050 | 2018-08-06 | 30-day Notice |
| S049 | 2018-06-27 | 30-day Notice |
| S048 | ||
| S047 | 2017-06-08 | Real-time Process |
| S046 | 2017-02-22 | Real-time Process |
| S045 | 2015-09-21 | Real-time Process |
| S044 | 2015-02-12 | Special (immediate Track) |
| S043 | 2015-02-03 | 30-day Notice |
| S042 | 2015-02-02 | 30-day Notice |
| S041 | 2015-02-02 | 30-day Notice |
| S040 | 2015-01-27 | Normal 180 Day Track |
| S039 | 2014-12-09 | 30-day Notice |
| S038 | 2014-10-15 | Special (immediate Track) |
| S037 | 2014-08-01 | Special (immediate Track) |
| S036 | 2014-02-14 | 135 Review Track For 30-day Notice |
| S035 | 2013-12-20 | 30-day Notice |
| S034 | 2013-10-23 | Normal 180 Day Track |
| S033 | 2013-04-01 | Real-time Process |
| S032 | 2013-01-22 | 30-day Notice |
| S031 | 2013-01-18 | 30-day Notice |
| S030 | 2013-01-08 | Real-time Process |
| S029 | 2012-12-14 | Real-time Process |
| S028 | 2012-03-26 | 30-day Notice |
| S027 | 2011-09-26 | Real-time Process |
| S026 | 2011-08-29 | 30-day Notice |
| S025 | 2011-07-22 | 30-day Notice |
| S024 | 2011-05-02 | Real-time Process |
| S023 | 2011-04-26 | 30-day Notice |
| S022 | 2010-12-02 | Real-time Process |
| S021 | 2010-06-14 | 30-day Notice |
| S020 | ||
| S019 | 2010-04-06 | 30-day Notice |
| S018 | 2009-12-22 | 30-day Notice |
| S017 | 2010-01-19 | Real-time Process |
| S016 | ||
| S015 | 2009-08-14 | 30-day Notice |
| S014 | 2008-12-12 | 135 Review Track For 30-day Notice |
| S013 | 2008-11-24 | 30-day Notice |
| S012 | 2008-10-17 | Real-time Process |
| S011 | 2008-08-19 | Real-time Process |
| S010 | 2008-04-25 | Normal 180 Day Track No User Fee |
| S009 | 2008-03-11 | Real-time Process |
| S008 | ||
| S007 | 2006-08-16 | Normal 180 Day Track |
| S006 | ||
| S005 | 2004-12-30 | Real-time Process |
| S004 | 2004-04-01 | 30-day Notice |
| S003 | 2002-10-17 | Normal 180 Day Track |
| S002 | 2002-08-07 | Normal 180 Day Track |
| S001 | 2001-05-17 | Normal 180 Day Track |