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: adding a cuff stabilizer sheath, modifying the suture indicator knots and updating labeling. The device, as modified, will be marketed under the trade name fish- sp advanced compression device and is indicated for "... 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, 7 or 8 french procedural sheaths. "
| Device | FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | MORRIS INNOVATIVE RESEARCH INC |
| Date Received | 2011-05-12 |
| Decision Date | 2011-07-11 |
| PMA | P050043 |
| Supplement | S005 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MORRIS INNOVATIVE RESEARCH INC 907 W.second St bloomington, IN 47403 |
| 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 |