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 | Durasphere Injectable Bulking Agent |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC.1290 Hammond Rd.st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-27 |
| Decision Date | 2022-10-27 |
| PMA | P980053 |
| Supplement | S019 |
| Product Code | LNM |
| 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 | CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd. st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM 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 a Change In The Sterilization Process Parameters Within The Existing Sterilization Facility |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980053 | Original Filing | |
| S019 | 2022-09-27 | 30-day Notice |
| S018 | 2020-12-28 | Normal 180 Day Track No User Fee |
| S017 | 2019-08-01 | 30-day Notice |
| S016 | 2016-03-09 | Special (immediate Track) |
| S015 | 2013-07-22 | 30-day Notice |
| S014 | 2013-02-19 | 30-day Notice |
| S013 | 2010-12-23 | 30-day Notice |
| S012 | ||
| S011 | 2007-12-11 | 30-day Notice |
| S010 | 2006-02-23 | 30-day Notice |
| S009 | 2005-01-06 | Normal 180 Day Track No User Fee |
| S008 | 2004-12-22 | Normal 180 Day Track |
| S007 | 2004-06-29 | Normal 180 Day Track |
| S006 | 2003-03-07 | Normal 180 Day Track |
| S005 | 2002-11-29 | Normal 180 Day Track |
| S004 | 2002-02-26 | Normal 180 Day Track |
| S003 | 2001-03-12 | Normal 180 Day Track |
| S002 | 2001-01-09 | 30-day Notice |
| S001 | 2000-10-06 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00858015005004 | P980053 | 003 |
| 00858015005011 | P980053 | 005 |