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 new balloon sizes to be added to the falcon 20 coronary balloon dilatation catheter line and the addtion of the falcon 30 and falcon 40 coroanry balloon dilatation catheter lines. Also, specification and quality control inspection changes were requested
| Device | MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1996-06-24 |
| Decision Date | 1996-08-30 |
| PMA | P870036 |
| Supplement | S039 |
| 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 |