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: STARCLOSE VASCULAR CLOSURE SYSTEM
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular closure system
• Applicant: ABBOTT VASCULAR INC.
• PMA Number: P050007
• Supplement Number: S011
• Date Received: 08/15/2008
• Decision Date: 09/12/2008
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Modification to the sterilization cycle for the device.