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 use of an alternate adhesive on hte referenced ptca catheters (versaflex buchbinder omniflex ptca catheter system - medtronic 18k, 18k with tip marker, 14k, 14k long, panther, panther 30, and panther 40 ptca catheters)
| Device | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40 |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1995-11-01 |
| Decision Date | 1995-12-07 |
| PMA | P870036 |
| Supplement | S037 |
| 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 |