PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM

FDA Premarket Approval P900052 S010

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 the manufacturing facility located at the finishing/polishing facility located at eltronic, coon rapids, minnesota.

DevicePORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
Generic NameCatheter, Percutaneous, Long Term, Intraspinal
ApplicantSMITHS MEDICAL ASD, INC.
Date Received2001-10-31
Decision Date2002-06-11
PMAP900052
SupplementS010
Product CodeLNY 
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P900052Original Filing
S018 2013-04-22 30-day Notice
S017 2009-09-21 Real-time Process
S016 2008-08-11 Real-time Process
S015 2007-05-25 135 Review Track For 30-day Notice
S014 2006-12-08 135 Review Track For 30-day Notice
S013 2006-07-26 135 Review Track For 30-day Notice
S012 2002-10-30 Real-time Process
S011 2002-09-04 30-day Notice
S010 2001-10-31 Normal 180 Day Track
S009 2001-09-11 30-day Notice
S008 1999-09-07 30-day Notice
S007 1999-02-11 Normal 180 Day Track
S006 1998-06-04 Normal 180 Day Track
S005 1998-04-07 Normal 180 Day Track
S004 1996-02-23 Normal 180 Day Track
S003 1995-06-26 Normal 180 Day Track
S002 1994-06-28 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
10610586013355 P900052 018
10610586013225 P900052 018
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