Premarket Approval (PMA)

Note: 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.

• Device: QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
• Generic Name: Device, hemostasis, vascular
• Applicant: SUB-Q, INC.; 1062-D CALLE NEGOCIO; SAN CLEMENTE, CA 92673
• PMA Number: P010049
• Date Received: 09/10/2001
• Decision Date: 03/25/2002
• Product Code: MGB
• Docket Number: 02M-0134
• Notice Date: 03/29/2002
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF GELFOAM FOR THE EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITE. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS. THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012