This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the femoral introducer sheath and hemostasis (fish) device 5, 6, and 8 french. The device is indicated as follows: the femoral introducer sheath and hemostasis (fish) device is intended for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5, 6, or 8 french procedural sheaths.
| Device | FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | MORRIS INNOVATIVE RESEARCH INC |
| Date Received | 2005-11-23 |
| Decision Date | 2007-08-20 |
| Notice Date | 2007-09-18 |
| PMA | P050043 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 07M-0344 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MORRIS INNOVATIVE RESEARCH INC 907 W.second St bloomington, IN 47403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050043 | Original Filing | |
| S008 | 2018-07-30 | 30-day Notice |
| S007 | ||
| S006 | 2012-01-13 | Real-time Process |
| S005 | 2011-05-12 | Real-time Process |
| S004 | 2011-01-18 | Real-time Process |
| S003 | ||
| S002 | 2009-05-26 | Real-time Process |
| S001 | 2008-05-07 | Real-time Process |