Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: VASOSEAL ES DEVICE
• Generic Name: Device, hemostasis, vascular
• Applicant: St. Jude Medical, Inc.; 177 E. County Rd. B E.; St Paul, MN 55117
• PMA Number: P920004
• Supplement Number: S013
• Date Received: 05/01/2000
• Decision Date: 08/03/2001
• Withdrawal Date: 12/06/2013
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL TO MODIFY THE IFU FOR THE VASOSEAL ES DEVICE TO INCLUDE ANGIOGRAPHY DATA.