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 Lake, NJ 07417
• PMA Number: P780011
• Supplement Number: S012
• Date Received: 08/29/1989
• Decision Date: 10/30/1989
• Withdrawal Date: 05/06/2009
• Product Code: KRD
• 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