Codman OR Prep Kits

FDA Premarket Approval P890055 S076

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 replacing 1 inch refill needles with previously approved 1. 5 inch refill needles in or prep kit and corresponding labeling edits

DeviceCodman OR Prep Kits
Generic NamePump, Infusion, Implanted, Programmable
ApplicantIntera Oncology
Date Received2020-11-17
Decision Date2020-12-16
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement Type30-day Notice
Supplement ReasonProcess 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
S076 2020-11-17 30-day Notice
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
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)
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
S043 2012-08-14 Real-time Process
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
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
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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