Note: 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. |
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Device | TORAY INOUE BALLOON 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 | S005 |
Date Received | 04/19/2011 |
Decision Date | 05/17/2011 |
Product Code |
MAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A STERILIZER AT YOUR SETA PLANT FACILITY. |
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