This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for: 1) revision of the current titan prosthesis to include a new one-touch release pump body; 2) addition of nusil technology med-4755 silicone as an optional alternative to the currently used nusil technology med-4515 and med-4750 silicones; 3) addition of a 1. 5cm rear tip extender in the titan assembly kits; 4) addition of a specification imposing a lower limit of 2. 5 lb for tactile force for deflation using the otr pump; and 5) labeling revisions relating to the above device changes. The device, as modified, will be marketed under the trade name titan otr inflatable penile prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
| Device | COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS |
| Classification Name | Device, Impotence, Mechanical/hydraulic |
| Generic Name | Device, Impotence, Mechanical/hydraulic |
| Applicant | COLOPLAST CORP. |
| Date Received | 2006-08-16 |
| Decision Date | 2008-06-13 |
| PMA | P000006 |
| Supplement | S007 |
| Product Code | FHW |
| 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 | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 |
| 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 |