MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Premarket Approval P890055 S050

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

Removal of a duplicate visual inspection performed on two accessory components packaged with the medstream intrathecal catheter.

• Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
• Classification Name: Pump, Infusion, Implanted, Programmable
• Generic Name: Pump, Infusion, Implanted, Programmable
• Applicant: CODMAN
• Date Received: 2013-08-30
• Decision Date: 2013-09-23
• PMA: P890055
• Supplement: S050
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: CODMAN 325 Paramount Dr. raynham, MA 02767

Supplemental Filings

Supplement Number	Date	Supplement Type
P890055		Original Filing
S083	2022-08-30	30-day Notice
S082
S081	2022-05-27	Special (immediate Track)
S080	2022-04-26	30-day Notice
S079	2022-01-14	30-day Notice
S078	2021-11-23	30-day Notice
S077	2021-03-26	30-day Notice
S076	2020-11-17	30-day Notice
S075
S074
S073	2020-01-09	Normal 180 Day Track No User Fee
S072	2018-10-05	30-day Notice
S071	2017-12-13	30-day Notice
S070	2017-09-22	30-day Notice
S069	2017-08-21	Special (immediate Track)
S068	2017-06-08	30-day Notice
S067	2017-05-16	Real-time Process
S066	2017-02-01	30-day Notice
S065	2016-08-29	30-day Notice
S064	2016-08-02	30-day Notice
S063	2016-07-19	30-day Notice
S062	2016-04-27	30-day Notice
S061	2015-09-08	30-day Notice
S060	2015-06-24	30-day Notice
S059	2014-12-18	30-day Notice
S058
S057	2014-06-06	Normal 180 Day Track No User Fee
S056	2014-05-01	Real-time Process
S055	2014-04-28	Special (immediate Track)
S054
S053	2013-12-23	Special (immediate Track)
S052	2013-12-12	30-day Notice
S051	2013-08-30	30-day Notice
S050	2013-08-30	30-day Notice
S049	2013-08-22	Special (immediate Track)
S048	2013-06-28	Special (immediate Track)
S047	2012-11-07	Real-time Process
S046	2012-09-20	Real-time Process
S045	2012-09-13	Real-time Process
S044
S043	2012-08-14	Real-time Process
S042
S041	2012-05-29	30-day Notice
S040	2012-05-14	Real-time Process
S039	2012-03-16	Real-time Process
S038	2011-12-21	30-day Notice
S037
S036
S035	2011-09-30	135 Review Track For 30-day Notice
S034	2011-05-25	Special (immediate Track)
S033	2011-01-28	Real-time Process
S032	2011-03-01	Real-time Process
S031	2011-01-18	Normal 180 Day Track
S030	2011-01-18	Normal 180 Day Track No User Fee
S029	2011-01-18	Normal 180 Day Track No User Fee
S028	2011-01-18	Normal 180 Day Track No User Fee
S027	2010-11-24	30-day Notice
S026	2007-12-11	Normal 180 Day Track
S025	2007-12-11	Normal 180 Day Track
S024	2007-11-19	30-day Notice
S023	2007-10-23	Real-time Process
S022
S021	2007-08-06	Normal 180 Day Track No User Fee
S020	2007-08-06	30-day Notice
S019	2006-09-28	Real-time Process
S018	2004-03-22	Real-time Process
S017	2003-11-24	Normal 180 Day Track No User Fee
S016	2003-07-16	Real-time Process
S015	2002-06-21	Normal 180 Day Track
S014	2002-03-07	Real-time Process
S013	2001-06-06	Normal 180 Day Track
S012	2001-04-02	Real-time Process
S011	1999-10-12	Real-time Process
S010	1999-05-11	Real-time Process
S009	1999-02-23	Normal 180 Day Track
S008	1999-02-05	Normal 180 Day Track
S007	1998-05-27	Normal 180 Day Track
S006	1997-09-30	Normal 180 Day Track
S005	1997-09-09	Normal 180 Day Track
S004	1997-06-24	Normal 180 Day Track
S003	1997-02-26	Normal 180 Day Track
S002	1996-06-28	Normal 180 Day Track
S001	1996-06-05	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
10886704043591	P890055	001
10886704043607	P890055	001
10886704043614	P890055	001
10886704043621	P890055	001
10886704072553	P890055	005
10886704043775	P890055	010
10886704078838	P890055	010
20886704043741	P890055	010
20886704043727	P890055	010
10886704043768	P890055	011
20886704043826	P890055	012
10886704043751	P890055	016
10886704034995	P890055	018
10886704072560	P890055	018
20886704043710	P890055	021
20886704072888	P890055	021
20886704043734	P890055	021
20886704071454	P890055	026
10886704064923	P890055	026
10886704064930	P890055	026
10886704071433	P890055	026
20886704064951	P890055	031
10886704072072	P890055	031
10850014110021	P890055	073
00850014110079	P890055	073
10850014110045	P890055	073
10850014110052	P890055	073
00850014110147	P890055	074
00850014110154	P890055	076
00850014110093	P890055	077