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 | 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 | S001 |
Date Received | 05/22/1995 |
Decision Date | 11/30/1995 |
Product Code |
MAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE |
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