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 modifications to the inoue balloon catheter which is indicated for percutaneous transvenous mitral commissurotomy in patients with hemodynamically significant mitral valvular stenosis resulting primarily from commissural fusion of the mitral valve cusps.
| Device | INOUE BALLOON CATHETER |
| Classification Name | Catheter, Percutaneous (valvuloplasty) |
| Generic Name | Catheter, Percutaneous (valvuloplasty) |
| Applicant | Toray Industries (America), Inc. |
| Date Received | 2001-05-21 |
| Decision Date | 2002-02-13 |
| PMA | P910054 |
| Supplement | S002 |
| Product Code | MAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |