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.
| Device | Coloplast Saline-Filled Testicular Prosthesis (Torosa) |
| Generic Name | Prosthesis, Testicular |
| Applicant | COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS010 Date Received07/27/2022 Decision Date08/24/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-27 |
| Decision Date | 2022-08-24 |
| PMA | P020003 |
| Supplement | S010 |
| Product Code | FAF |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411 PMA NumberP020003 Supplement NumberS010 Date Received07/27/2022 Decision Date08/24/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of The Kinetic Turbidimetric Method To Perform Bacterial Endotoxin Testing For The Coloplast Saline-Filled Testicular Prosthesis (Torosa) |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020003 | Original Filing | |
| S011 | 2022-08-17 | 30-day Notice |
| S010 | 2022-07-27 | 30-day Notice |
| S009 | 2019-09-27 | 30-day Notice |
| S008 | 2018-08-06 | 30-day Notice |
| S007 | 2010-08-18 | Normal 180 Day Track No User Fee |
| S006 | 2008-11-24 | 30-day Notice |
| S005 | 2007-07-23 | Normal 180 Day Track No User Fee |
| S004 | 2006-05-18 | 135 Review Track For 30-day Notice |
| S003 | 2004-07-13 | Special (immediate Track) |
| S002 | 2004-02-17 | 30-day Notice |
| S001 | 2002-11-07 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 05708932470858 | P020003 | 007 |
| 05708932470834 | P020003 | 007 |
| 05708932470810 | P020003 | 007 |
| 05708932470797 | P020003 | 007 |