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 modifications to the delivery cannulae and the procoagulant and changing the buffering agent in the dilutent to tromethamine usp (tris). The device, as modified, will be marketed under the trade name duett flowable hemostat device and is indicated for use as adjunct treatment in obtaining hemostasis in sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture mediated/collagen-based hemostatic devices.
| Device | VASCULAR SOLUTION DUETT SEALING DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Vascular Solutions, Inc. |
| Date Received | 2001-12-11 |
| Decision Date | 2002-05-29 |
| PMA | P990037 |
| Supplement | S008 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |