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: ANGIOLINK VASCULAR CLOSURE SYSTEM
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular hemostasis device
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P040022
• Supplement Number: S001
• Date Received: 05/15/2006
• Decision Date: 10/02/2006
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for various manufacturing process changes to ensure consistency.