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Device | ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S034 |
Date Received | 11/05/2002 |
Decision Date | 12/20/2002 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF CLINICAL DATA RELATED TO USE OF THE ANGIO-SEAL STS 6FR DEVICE IN DIAGNOSTIC PATIENTS. |