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.
| Device | Intera 3000 Hepatic Artery Infusion Pump |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-30 |
| Decision Date | 2022-09-29 |
| PMA | P890055 |
| Supplement | S083 |
| 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 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement for Supplier Change For A Component Used In The Intera 3000 Hepatic Artery Infusion Pump |
| 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 |
| 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 |