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 new product line. The device, as modified, will be marketed under the trade name medtronic(r) achiever(tm) coronary balloon dilatation catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
| Device | THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1998-05-20 |
| Decision Date | 1998-11-17 |
| PMA | P870036 |
| Supplement | S044 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |