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: MINI BALLOON
• Generic Name: Device, Vascular, for Promoting Embolization
• Regulation Number: 870.3300
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC; ONE BECTON DR.; FRANKLIN LAKES, NJ 07417-1880
• PMA Number: P780011
• Supplement Number: S005
• Date Received: 05/12/1981
• Decision Date: 11/27/1981
• Withdrawal Date: 05/06/2009
• Product Code: KRD
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No