DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT

Catheter, Percutaneous, Long Term, Intraspinal

FDA Premarket Approval P860064

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

DeviceDAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT
Classification NameCatheter, Percutaneous, Long Term, Intraspinal
Generic NameCatheter, Percutaneous, Long Term, Intraspinal
ApplicantC.R. Bard, Inc.
Date Received1986-12-12
Decision Date1988-02-29
Notice Date1988-05-03
PMAP860064
SupplementS
Product CodeLNY
Docket Number88M-0092
Advisory CommitteeGeneral Hospital
Expedited ReviewNo
Combination Product No
Applicant Address C.R. Bard, Inc. 605 N 5600 W salt Lake City, UT 84116

Supplemental Filings

Supplement NumberDateSupplement Type
P860064Original Filing
S010 2001-11-14 30-day Notice
S009 1998-01-15 Real-time Process
S008 1997-05-05 Normal 180 Day Track
S007
S006 1991-02-27 Normal 180 Day Track
S005 1990-09-07 Normal 180 Day Track
S004 1989-12-27 Normal 180 Day Track
S003 1989-07-24 Normal 180 Day Track
S002 1988-09-06 Normal 180 Day Track
S001 1988-08-22 Normal 180 Day Track

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