Approval for the hancock apical left ventricle connector, model 174a. The device is indicated for providing an alternative method for relief of left ventricularhypertension in patients with severe left ventricular outflow tract obstruction due to hypoplasia ofthe aortic root, hypoplasia of the aortic annulus, or acquired problems secondary to aortic valve replacement which cannot be relieved through conventional techniques.
| Device | HANCOCK APICAL LEFT VENTRICLE CONNECTOR |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 2010-03-31 |
| Decision Date | 2010-09-20 |
| PMA | P870078 |
| Supplement | S008 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 E. Deere Avenue santa Ana, CA 92705 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P870078 | | Original Filing |
| S049 |
2020-11-19 |
30-day Notice |
| S048 | | |
| S047 |
2019-09-26 |
Real-time Process |
| S046 |
2019-06-20 |
30-day Notice |
| S045 |
2019-01-29 |
30-day Notice |
| S044 | | |
| S043 |
2018-10-01 |
30-day Notice |
| S042 |
2018-06-21 |
30-day Notice |
| S041 |
2018-04-12 |
30-day Notice |
| S040 |
2017-12-20 |
30-day Notice |
| S039 | | |
| S038 |
2017-09-11 |
30-day Notice |
| S037 |
2017-08-14 |
135 Review Track For 30-day Notice |
| S036 |
2017-07-10 |
30-day Notice |
| S035 |
2017-02-08 |
30-day Notice |
| S034 |
2016-10-25 |
30-day Notice |
| S033 |
2016-09-22 |
30-day Notice |
| S032 |
2016-05-06 |
30-day Notice |
| S031 |
2016-01-29 |
Real-time Process |
| S030 |
2015-10-13 |
30-day Notice |
| S029 |
2014-11-07 |
30-day Notice |
| S028 |
2014-10-14 |
30-day Notice |
| S027 |
2014-08-05 |
30-day Notice |
| S026 |
2014-06-23 |
30-day Notice |
| S025 |
2014-04-23 |
30-day Notice |
| S024 |
2013-10-25 |
Real-time Process |
| S023 |
2013-09-27 |
30-day Notice |
| S022 |
2013-07-01 |
30-day Notice |
| S021 |
2013-04-02 |
135 Review Track For 30-day Notice |
| S020 |
2013-04-01 |
135 Review Track For 30-day Notice |
| S019 |
2013-04-01 |
30-day Notice |
| S018 |
2012-12-13 |
30-day Notice |
| S017 |
2012-11-19 |
30-day Notice |
| S016 | | |
| S015 |
2012-03-23 |
Normal 180 Day Track |
| S014 | | |
| S013 |
2010-10-21 |
30-day Notice |
| S012 |
2010-10-20 |
30-day Notice |
| S011 |
2010-10-14 |
30-day Notice |
| S010 |
2010-06-18 |
30-day Notice |
| S009 |
2010-04-30 |
30-day Notice |
| S008 |
2010-03-31 |
Normal 180 Day Track |
| S007 |
2010-01-06 |
30-day Notice |
| S006 |
2008-09-02 |
Normal 180 Day Track |
| S005 |
1999-08-31 |
Normal 180 Day Track |
| S004 |
1998-04-06 |
Normal 180 Day Track |
| S003 |
1992-12-18 |
Normal 180 Day Track |
| S002 |
1992-07-20 |
Normal 180 Day Track |
| S001 |
1989-10-13 |
Normal 180 Day Track |
NIH GUDID Devices