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.
Alternate supplier for the polytetrafluoroethylene (ptfe) fabric constructed of ptfe yarn. This fabric is used to manufacture the sewing ring component for the medtronic hall prosthetic heart valve, model a7700, sizes 20, 22, and 24 mm.
| Device | MEDTRONIC HALL PROSTHETIC HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC CARDIAC SURGERY |
| Date Received | 2000-10-17 |
| Decision Date | 2000-11-09 |
| PMA | P790018 |
| Supplement | S036 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |