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 to extent the shelf life of the sodium phosphate procoagulant diluent, used only in the duet pro sealing device, model 1010, from 2 years to 5 years.
| Device | DUETT PRO SEALING DEVICE, MODEL 1010 |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Vascular Solutions, Inc. |
| Date Received | 2008-10-21 |
| Decision Date | 2008-12-17 |
| PMA | P990037 |
| Supplement | S028 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |