Approval for the arrow model 3000-16 constant flow implantable pump with bolus safety valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2)the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (fudr), heparinized saline, normal saline, and bacteriostatic water.
| Device | ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | CODMAN |
| Date Received | 1997-06-24 |
| Decision Date | 1998-03-17 |
| PMA | P890055 |
| Supplement | S004 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CODMAN 325 Paramount Dr. raynham, MA 02767 |
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