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: EXOSEAL VASCULAR CLOSURE DEVICE
• Classification Name: device, hemostasis, vascular
• Applicant: CORDIS CORPORATION
• PMA Number: P100013
• Supplement Number: S006
• Date Received: 09/13/2012
• Decision Date: 10/12/2012
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
An alternate tool for positioning a component and the addition of two optical sensors.