Approval for a change in the firms responsible for receiving and inspection activities for the barbed connector and tapered catheter components, cleaning and passivating of the barbed connector component, and packaging, sealing, and labeling of the barbed connector and tapered catheter components for the intera 3000 hepatic artery infusion pump
| Device | Intera 3000 Hepatic Artery Infusion Pump accessories |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | Intera Oncology |
| Date Received | 2021-03-26 |
| Decision Date | 2021-04-13 |
| PMA | P890055 |
| Supplement | S077 |
| 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 | Yes |
| Applicant Address | Intera Oncology 65 William Street suite 200 wellesley, MA 02481 |
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