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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 | S011 |
Date Received | 11/28/1997 |
Decision Date | 12/23/1997 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the in-coming specifications for the anchor material. |