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.
Change to the raw material of the dilator accessory.
| Device | Inoue Balloon Catheter |
| Generic Name | Catheter, Percutaneous (valvuloplasty) |
| Applicant | Toray Industries (America), Inc. |
| Date Received | 2020-03-04 |
| Decision Date | 2020-03-30 |
| PMA | P910054 |
| Supplement | S007 |
| 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 |