Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular hemostasis device
• Applicant: SUB-Q, INC.
• PMA Number: P010049
• Supplement Number: S005
• Date Received: 02/21/2003
• Decision Date: 03/12/2003
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for two labeling additions to the approved premarket approval application.