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: PROSTAR XL 8 & 10F PVS SYSTEM
• Classification Name: device, hemostasis, vascular
• Applicant: ABBOTT VASCULAR DEVICES
• PMA Number: P960043
• Supplement Number: S058
• Date Received: 10/12/2005
• Decision Date: 03/31/2006
• 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 revised instructions for use.