|
Device | CLOSER VASCULAR SEALING SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | REX MEDICAL, L.P. 555 E. NORTH LANE SUITE 5035 CONSHOHOCKEN, PA 19428 |
PMA Number | P150022 |
Date Received | 06/25/2015 |
Decision Date | 02/12/2016 |
Product Code |
MGB |
Docket Number | 16M-0805 |
Notice Date | 03/03/2016 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S007 |