MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Premarket Approval P780011

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceMINI BALLOON
Classification NameDevice, Vascular, For Promoting Embolization
Generic NameDevice, Vascular, For Promoting Embolization
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Received1978-11-27
Decision Date1980-05-15
PMAP780011
SupplementS
Product CodeKRD
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC one Becton Dr. franklin Lakes, NJ 07417-1880

Supplemental Filings

Supplement NumberDateSupplement Type
P780011Original 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

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