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: VASCULAR CLOSURE SYSTEMS
• Generic Name: Device, hemostasis, vascular
• Applicant: ABBOTT VASCULAR DEVICES; 3200 LAKESIDE DRIVE; SANTA CLARA, CA 95054
• PMA Number: P050007
• Supplement Number: S029
• Date Received: 07/18/2011
• Decision Date: 08/10/2011
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGE IN BET LOCATION AND TECHNIQUE.