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: ANGIO-SEAL VASCULAR CLOSURE DEVICE
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular hemostasis device
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P930038
• Supplement Number: S068
• Date Received: 09/22/2011
• Decision Date: 10/18/2011
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to increase the denaturation temperature range to 42. 41 ¿ 53. 3¿c.