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 a manufacturing site located at biotest laboratories, inc. Minneapolis, minnesota.
| Device | MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC CARDIAC SURGERY |
| Date Received | 2003-11-12 |
| Decision Date | 2003-11-28 |
| PMA | P790018 |
| Supplement | S045 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| 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 |