This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | INOUE BALLOON CATHETER |
| Classification Name | Catheter, Percutaneous (valvuloplasty) |
| Generic Name | Catheter, Percutaneous (valvuloplasty) |
| Applicant | Toray Industries (America), Inc. |
| Date Received | 1991-09-09 |
| Decision Date | 1994-06-28 |
| Notice Date | 1994-08-25 |
| PMA | P910054 |
| Supplement | S |
| Product Code | MAD |
| Docket Number | 94M-0269 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor new York, NY 10017 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910054 | Original Filing | |
| S008 | 2021-08-13 | 30-day Notice |
| S007 | 2020-03-04 | 30-day Notice |
| S006 | 2018-09-04 | 30-day Notice |
| S005 | 2011-04-19 | 30-day Notice |
| S004 | 2006-11-15 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2001-05-21 | Normal 180 Day Track |
| S001 | 1995-05-22 | Normal 180 Day Track |