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.
Approval for the hall easy-fit prosthetic heart valve, models a7700 (aortic) and m7700 (mitral), available in aortic sizes 19, 21, 23, 25, 27, and 29 mm, and in mitral sizes 23, 25, 27, 29, and 31 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves. The hall prosthetic heart valve is a modification of the approved medtronic hal prosthetic heart valve; the modification consisting of a new sewing cuff material and design, intended for supra-annular placement. The supplement additionally requested introduction of the hall e prosthetic heart valve product line into the approved steam sterilization process for the medtronic h prosthetic heart valve.
| Device | HALL (TM) EASY-FIT PROSTHETIC HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC CARDIAC SURGERY |
| Date Received | 2001-04-19 |
| Decision Date | 2001-11-09 |
| PMA | P790018 |
| Supplement | S037 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC CARDIAC SURGERY 8299 Central Ave., N.e. spring Lake Park, MN 55432-3576 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790018 | Original Filing | |
| S052 | 2009-06-09 | 30-day Notice |
| S051 | 2009-02-24 | Special (immediate Track) |
| S050 | 2008-11-10 | 30-day Notice |
| S049 | 2008-08-11 | 30-day Notice |
| S048 | 2008-05-27 | 30-day Notice |
| S047 | 2006-12-26 | 30-day Notice |
| S046 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S045 | 2003-11-12 | Normal 180 Day Track No User Fee |
| S044 | 2003-08-29 | 30-day Notice |
| S043 | 2002-03-22 | Normal 180 Day Track |
| S042 | 2001-12-26 | Special (immediate Track) |
| S041 | 2001-11-19 | Normal 180 Day Track |
| S040 | 2001-11-19 | 30-day Notice |
| S039 | 2001-11-05 | Normal 180 Day Track |
| S038 | 2001-11-05 | Special (immediate Track) |
| S037 | 2001-04-19 | Real-time Process |
| S036 | 2000-10-17 | 30-day Notice |
| S035 | 1999-08-31 | Normal 180 Day Track |
| S034 | 1998-10-27 | 30-day Notice |
| S033 | 1998-07-14 | Normal 180 Day Track |
| S032 | 1998-01-30 | Normal 180 Day Track |
| S031 | 1997-07-21 | Normal 180 Day Track |
| S030 | 1997-03-13 | Normal 180 Day Track |
| S029 | 1997-02-21 | Normal 180 Day Track |
| S028 | 1996-07-23 | Normal 180 Day Track |
| S027 | ||
| S026 | 1995-11-01 | Normal 180 Day Track |
| S025 | 1995-02-27 | Normal 180 Day Track |
| S024 | 1995-01-18 | Normal 180 Day Track |
| S023 | 1994-03-25 | Normal 180 Day Track |
| S022 | 1993-09-23 | Normal 180 Day Track |
| S021 | 1993-01-06 | Normal 180 Day Track |
| S020 | 1992-04-16 | Normal 180 Day Track |
| S019 | 1992-05-26 | Normal 180 Day Track |
| S018 | 1992-01-10 | Special (immediate Track) |
| S017 | 1991-12-10 | Normal 180 Day Track |
| S016 | 1989-05-08 | Normal 180 Day Track |
| S015 | ||
| S014 | 1985-12-06 | |
| S013 | 1985-12-04 | |
| S012 | 1984-12-06 | |
| S011 | ||
| S010 | 1984-05-02 | |
| S009 | ||
| S008 | 1983-09-22 | |
| S007 | 1984-02-29 | |
| S006 | 1983-12-07 | |
| S005 | 1983-06-13 | |
| S004 | 1982-11-24 | |
| S003 | 1982-07-29 | |
| S002 | 1982-02-12 | |
| S001 | 1982-02-02 |