PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST

FDA Premarket Approval P900052 S006

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 a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.

• Device: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
• Generic Name: Catheter, Percutaneous, Long Term, Intraspinal
• Applicant: SMITHS MEDICAL ASD, INC.
• Date Received: 1998-06-04
• Decision Date: 1998-09-15
• PMA: P900052
• Supplement: S006
• Product Code: LNY
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• Combination Product: No
• Applicant Address: SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road st. Paul, MN 55112

Supplemental Filings

Supplement Number	Date	Supplement Type
P900052		Original 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 ID	PMA	Supp
10610586013355	P900052	018
10610586013225	P900052	018