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ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE

FDA premarket approval P930038/S054 · decided 2008-03-18

Approval details

PMA number
P930038
Supplement
S054
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE
Generic name
Device, hemostasis, vascular
Applicant
Terumo Medical Corporation
Date received
2008-01-22
Decision date
2008-03-18
Days to decision
56 days
Decision code
APPR
Product code
MGB
Advisory committee
Cardiovascular
Expedited review
No
Location
Elkton, MD
Statement
APPROVAL FOR DEVICE MODIFICATIONS TO THE ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE INCLUDING UTILIZING AN AUTOMATED COLLAGEN COMPACTION MECHANISM FOR EASE OF USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES U

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