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.
Addition of new packaging heat sealing equipment.
| Device | Toray Inoue Balloon Catheter |
| Classification Name | Catheter, Percutaneous (valvuloplasty) |
| Generic Name | Catheter, Percutaneous (valvuloplasty) |
| Applicant | Toray Industries (America), Inc. |
| Date Received | 2018-09-04 |
| Decision Date | 2018-09-13 |
| PMA | P910054 |
| Supplement | S006 |
| Product Code | MAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |