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 three larger cylinder sizes (i. E. , lengths of 24, 26, and28 cm), and related changes for larger packaging, a modification to the cylinder manufacturingprocess, additional labels for the larger cylinder sizes, revised instructions for use to include additional catalog numbers for the new cylinder sizes, and a new labeling statement that recommends use of the l00cc reservoir with the new larger cylinder sizes.
| Device | TITAN INFLATABLE PENILE PROSTHESIS |
| Classification Name | Device, Impotence, Mechanical/hydraulic |
| Generic Name | Device, Impotence, Mechanical/hydraulic |
| Applicant | COLOPLAST CORP. |
| Date Received | 2008-10-17 |
| Decision Date | 2008-12-19 |
| PMA | P000006 |
| Supplement | S012 |
| 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 |