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 closer vascular sealing system (vss). This device is indicated for the percutaneous closure of femoral artery access sites while reducing times to hemostasis and ambulation as compared to performance goals in patients who have undergone diagnostic or interventional endovascular procedures utilizing 5, 6 and 7 fr procedural sheaths.
| Device | CLOSER VASCULAR SEALING SYSTEM |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | REX MEDICAL, L.P. |
| Date Received | 2015-06-25 |
| Decision Date | 2016-02-12 |
| Notice Date | 2016-03-03 |
| PMA | P150022 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 16M-0805 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | REX MEDICAL, L.P. 555 E. North Lane Suite 5035 conshohocken, PA 19428 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150022 | Original Filing | |
| S007 | 2018-09-11 | 30-day Notice |
| S006 | ||
| S005 | 2018-05-21 | Real-time Process |
| S004 | 2018-01-08 | Special (immediate Track) |
| S003 | 2017-11-02 | Real-time Process |
| S002 | 2016-08-15 | Real-time Process |
| S001 | 2016-03-15 | Real-time Process |