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 the change in diluent and procoagulant components. The device, as modified, will be marketed under the trade name diagnostic duett and is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5f-9f introducer sheath with an overall length not exceeding 15. 2 cm.
| Device | DIAGNOSTIC DUETT |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Vascular Solutions, Inc. |
| Date Received | 2000-10-04 |
| Decision Date | 2001-11-02 |
| PMA | P990037 |
| Supplement | S001 |
| 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 |