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 the following modifications to the titan narrow basecylinder (11 and 14 cm lengths only): (i) change of the angle of the tubing from 22. 5° to 0°, and (ii) change in cylinder tip material from dipped-on bioflex to bonded-on med 4750.
| Device | TITAN INFLATABLE PENILE PROSTHESIS |
| Classification Name | Device, Impotence, Mechanical/hydraulic |
| Generic Name | Device, Impotence, Mechanical/hydraulic |
| Applicant | COLOPLAST CORP. |
| Date Received | 2012-12-14 |
| Decision Date | 2013-01-29 |
| PMA | P000006 |
| Supplement | S029 |
| 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 |