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 modifications to the deflation button and valve of the pump component, and related changes to the labeling to reflect these modifications.
| Device | TITAN INFLATABLE PENILE PROSTHESIS |
| Classification Name | Device, Impotence, Mechanical/hydraulic |
| Generic Name | Device, Impotence, Mechanical/hydraulic |
| Applicant | COLOPLAST CORP. |
| Date Received | 2013-04-01 |
| Decision Date | 2013-05-31 |
| PMA | P000006 |
| Supplement | S033 |
| Product Code | FHW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| 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 |