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Device | ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S012 |
Date Received | 12/18/1997 |
Decision Date | 06/16/1998 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in the design of the anchor and collagen sponge componenets of the Agnio-Seal(TM) device. |