DAVOL EXTERNALIZED EPIDURAL CATHETER

Catheter, Percutaneous, Long Term, Intraspinal

FDA Premarket Approval P860064 S005

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

DeviceDAVOL EXTERNALIZED EPIDURAL CATHETER
Classification NameCatheter, Percutaneous, Long Term, Intraspinal
Generic NameCatheter, Percutaneous, Long Term, Intraspinal
ApplicantC.R. Bard, Inc.
Date Received1990-09-07
Decision Date1990-10-19
PMAP860064
SupplementS005
Product CodeLNY
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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