MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Premarket Approval P780011 S012

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.

Pre-market Approval Supplement Details

• Device: MINI BALLOON
• Classification Name: Device, Vascular, For Promoting Embolization
• Generic Name: Device, Vascular, For Promoting Embolization
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
• Date Received: 1989-08-29
• Decision Date: 1989-10-30
• PMA: P780011
• Supplement: S012
• Product Code: KRD
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC one Becton Dr. franklin Lakes, NJ 07417-1880

Supplemental Filings

Supplement Number	Date	Supplement Type
P780011		Original Filing
S012	1989-08-29	Normal 180 Day Track
S011	1988-05-31	Normal 180 Day Track
S010	1987-05-01	Normal 180 Day Track
S009
S008
S007	1984-08-16
S006	1982-05-03
S005	1981-05-12
S004	1981-02-26
S003	1981-02-26
S002
S001	1981-02-26