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

DeviceMINI BALLOON
Classification NameDevice, Vascular, For Promoting Embolization
Generic NameDevice, Vascular, For Promoting Embolization
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Received1989-08-29
Decision Date1989-10-30
PMAP780011
SupplementS012
Product CodeKRD
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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