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 addition of the 7f fish-sp device to the fish product line. The device, as modified, will be marketed under the trade name 7f fish-sp device for closure and is indicated for percutaneous access and closure of the common femoral artery while reducing time to hemostasis, ambulation and time to eligible discharge in patients requiring access of 7f for endovascular procedure with sheath removal.
| Device | 7F FISH-SP DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | MORRIS INNOVATIVE RESEARCH INC |
| Date Received | 2009-05-26 |
| Decision Date | 2009-07-24 |
| PMA | P050043 |
| Supplement | S002 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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 |