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Device | ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S004 |
Date Received | 03/31/1997 |
Decision Date | 04/25/1997 |
Product Code |
MGB |
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 MODIFICATIONS TO THE ANGIO-SEAL(TM) MANUFACTURING PROCESS TO ELIMINATE THE POTENTIAL FOR DAMAGE OF THE SUTURE COMPONENT. |