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 a new version of the sub-intestinal submucosa (sis) material (version 2. 0).
| Device | FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | MORRIS INNOVATIVE RESEARCH INC |
| Date Received | 2012-01-13 |
| Decision Date | 2012-02-28 |
| PMA | P050043 |
| Supplement | S006 |
| 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 |