MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Premarket Approval P890055 S033

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 software modification to the medstream programmable infusion system. The modified medstream pump will have software ps-100044 version 3. 06, the modified control unit will have software ps-100046 version 3. 00. Ps-100045 version 3. 04, ps-1000047 version 3. 09 and ps-100021 version 2. 00. The device,as modified, will be marketed under the trade name medstream programmable infusion system and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5. 0 ph to 7. 0ph) in the treatment of severe spasticity.

DeviceMEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Classification NamePump, Infusion, Implanted, Programmable
Generic NamePump, Infusion, Implanted, Programmable
ApplicantCODMAN
Date Received2011-01-28
Decision Date2011-05-23
PMAP890055
SupplementS033
Product CodeLKK
Advisory CommitteeGeneral Hospital
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CODMAN 325 Paramount Dr. raynham, MA 02767

Supplemental Filings

Supplement NumberDateSupplement Type
P890055Original 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 IDPMASupp
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
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