DUPEN LONG TERM EPIDURAL CATHETER

Catheter, Percutaneous, Long Term, Intraspinal

FDA Premarket Approval P860064 S009

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

Approval for modifications to the instructions for use (ifu) for the dupen long term epidural catheter and the dupen catheter repair kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the repair kit ifu to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the repair kit ifu; 4) to add international units of measurea nd general international requirements; 5) to add a general biohazard statement concerning handling of product after use to the ifus and product labels; and 6) to add an international symbol (explained in the device ifu) tot he external catheter sleeve "attention, see instructions for use. "

DeviceDUPEN LONG TERM EPIDURAL CATHETER
Classification NameCatheter, Percutaneous, Long Term, Intraspinal
Generic NameCatheter, Percutaneous, Long Term, Intraspinal
ApplicantC.R. Bard, Inc.
Date Received1998-01-15
Decision Date1998-01-26
PMAP860064
SupplementS009
Product CodeLNY
Advisory CommitteeGeneral Hospital
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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