Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MINI BALLOON
• Classification Name: device, vascular, for promoting embolization
• Generic Name: device, embolization, arterial
• Regulation Number: 870.3300
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
• PMA Number: P780011
• Supplement Number: S012
• Date Received: 08/29/1989
• Decision Date: 10/30/1989
• Product Code: KRD [ Registered Establishments with KRD ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No