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.
Change in the tensile test method, which tests the functionality of the catheter using a method that aligns it with the required specification.
| Device | DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210 |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Vascular Solutions, Inc. |
| Date Received | 2003-06-18 |
| Decision Date | 2003-07-11 |
| PMA | P990037 |
| Supplement | S020 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Vascular Solutions, Inc. 6464 Sycamore Court North minneapolis, MN 55369 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990037 | Original Filing | |
| S036 | 2022-08-08 | Normal 180 Day Track |
| S035 | 2021-06-14 | 30-day Notice |
| S034 | 2016-09-09 | 30-day Notice |
| S033 | ||
| S032 | 2016-01-29 | Special (immediate Track) |
| S031 | 2010-07-30 | Normal 180 Day Track No User Fee |
| S030 | 2010-04-09 | 30-day Notice |
| S029 | 2009-11-04 | 30-day Notice |
| S028 | 2008-10-21 | Real-time Process |
| S027 | ||
| S026 | 2008-07-11 | 30-day Notice |
| S025 | 2007-06-14 | Special (immediate Track) |
| S024 | 2006-06-22 | Panel Track |
| S023 | 2005-08-05 | Special (immediate Track) |
| S022 | 2004-06-15 | Normal 180 Day Track No User Fee |
| S021 | 2004-06-15 | Real-time Process |
| S020 | 2003-06-18 | 30-day Notice |
| S019 | 2003-05-16 | Real-time Process |
| S018 | 2003-04-30 | Normal 180 Day Track No User Fee |
| S017 | ||
| S016 | ||
| S015 | 2003-03-11 | Real-time Process |
| S014 | 2003-02-24 | Special (immediate Track) |
| S013 | 2003-01-23 | 30-day Notice |
| S012 | 2003-01-17 | Real-time Process |
| S011 | 2002-08-26 | 30-day Notice |
| S010 | 2002-02-27 | Normal 180 Day Track |
| S009 | 2002-03-15 | Real-time Process |
| S008 | 2001-12-11 | Normal 180 Day Track |
| S007 | 2001-11-28 | Special (immediate Track) |
| S006 | 2001-05-21 | Special (immediate Track) |
| S005 | 2001-05-01 | Normal 180 Day Track |
| S004 | ||
| S003 | 2001-02-07 | Real-time Process |
| S002 | 2001-01-22 | Real-time Process |
| S001 | 2000-10-04 | Normal 180 Day Track |