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: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Generic Name: Device, hemostasis, vascular
• Applicant: Abbott Vascular Devices; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P050007
• Supplement Number: S033
• Date Received: 02/25/2015
• Decision Date: 10/09/2015
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., IN TIPPERARY IRELAND, AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND.