3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories

FDA Premarket Approval P890055 S073

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

Based upon the information submitted, the pma supplement is approved.

Device3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories
Generic NamePump, Infusion, Implanted, Programmable
ApplicantIntera Oncology
Date Received2020-01-09
Decision Date2020-02-07
PMAP890055
SupplementS073
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Intera Oncology 65 William Street suite 200 wellesley, MA 02481

Supplemental Filings

Supplement NumberDateSupplement Type
P890055Original Filing
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

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