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ANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS)

FDA premarket approval P930038/S029 · decided 2001-07-26

Approval details

PMA number
P930038
Supplement
S029
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS)
Generic name
Device, hemostasis, vascular
Applicant
Terumo Medical Corporation
Date received
2001-01-08
Decision date
2001-07-26
Days to decision
199 days
Decision code
APPR
Product code
MGB
Advisory committee
Cardiovascular
Expedited review
No
Location
Elkton, MD
Statement
APPROVAL FOR THE SELF-TIGHTENING SLIPKNOT (STS) MODIFICATION TO THE ANGIO-SEAL VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE: SELF-TIGHTENING SLIPKNOT (STS) AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERTONE A DIAGNOSTIC ANGIOGRAPHIC PROCEDURE OR AN INTERVENTIONAL PROCEDURE USING AN 8FRENCH PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL STS DEVI

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