|
Device | TORAY INOUE BALLON CATHETER |
Generic Name | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
Applicant | Toray Industries (America), Inc. 461 FIFTH AVENUE, 9TH FLOOR NEW YORK, NY 10017 |
PMA Number | P910054 |
Supplement Number | S004 |
Date Received | 11/15/2006 |
Decision Date | 07/03/2007 |
Product Code |
MAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE GUIDEWIRE AND STYLET BULK MATERIAL. |