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 addition of an accessory device, the folio balloon shaping tool, to your currently marketed line of medtronic (r) millenia(tm) coronary balloon dilatation catheters.
| Device | MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1997-01-29 |
| Decision Date | 1997-07-28 |
| PMA | P870036 |
| Supplement | S042 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONICS INTERVENTIONAL VASCULAR 3576 Uno Cal Place santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870036 | Original Filing | |
| S044 | 1998-05-20 | Normal 180 Day Track |
| S043 | 1997-03-03 | Normal 180 Day Track |
| S042 | 1997-01-29 | |
| S041 | 1996-11-21 | Normal 180 Day Track |
| S040 | 1996-09-19 | Special (immediate Track) |
| S039 | 1996-06-24 | Normal 180 Day Track |
| S038 | 1996-04-16 | Normal 180 Day Track |
| S037 | 1995-11-01 | Normal 180 Day Track |
| S036 | 1995-07-17 | Normal 180 Day Track |
| S035 | 1995-04-07 | 30-Day Supplement |
| S034 | 1995-01-31 | Normal 180 Day Track |
| S033 | ||
| S032 | 1994-10-17 | Normal 180 Day Track |
| S031 | 1994-06-27 | Normal 180 Day Track |
| S030 | 1994-03-09 | Normal 180 Day Track |
| S029 | 1994-03-03 | Normal 180 Day Track |
| S028 | 1994-01-24 | Normal 180 Day Track |
| S027 | 1993-07-30 | Normal 180 Day Track |
| S026 | 1993-03-29 | Normal 180 Day Track |
| S025 | 1993-03-01 | Normal 180 Day Track |
| S024 | 1993-02-01 | Normal 180 Day Track |
| S023 | 1993-01-05 | Normal 180 Day Track |
| S022 | ||
| S021 | 1992-11-16 | Normal 180 Day Track |
| S020 | 1992-10-07 | Normal 180 Day Track |
| S019 | 1992-09-16 | Normal 180 Day Track |
| S018 | 1992-05-26 | Normal 180 Day Track |
| S017 | 1992-02-11 | Normal 180 Day Track |
| S016 | ||
| S015 | 1991-11-21 | Normal 180 Day Track |
| S014 | 1991-09-12 | Normal 180 Day Track |
| S013 | 1991-08-29 | Normal 180 Day Track |
| S012 | 1991-08-23 | Normal 180 Day Track |
| S011 | 1991-02-08 | Normal 180 Day Track |
| S010 | 1990-12-14 | Normal 180 Day Track |
| S009 | 1990-11-08 | Normal 180 Day Track |
| S008 | 1990-08-08 | Normal 180 Day Track |
| S007 | 1989-11-03 | Normal 180 Day Track |
| S006 | 1989-08-21 | Normal 180 Day Track |
| S005 | 1989-04-20 | Normal 180 Day Track |
| S004 | 1989-03-03 | Normal 180 Day Track |
| S003 | 1989-02-21 | Normal 180 Day Track |
| S002 | 1989-02-17 | Normal 180 Day Track |
| S001 | 1988-04-12 | Normal 180 Day Track |