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ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM

FDA premarket approval P930038/S031 · decided 2001-08-28

Approval details

PMA number
P930038
Supplement
S031
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM
Generic name
Device, hemostasis, vascular
Applicant
Terumo Medical Corporation
Date received
2001-03-20
Decision date
2001-08-28
Days to decision
161 days
Decision code
APPR
Product code
MGB
Advisory committee
Cardiovascular
Expedited review
No
Location
Elkton, MD
Statement
APPROVAL FOR ADDING THE LOCKING CAP FEATURE ONTO THE DELIVERY SYSTEM OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE WITH SELF-TIGHTENING SLIPKNOT (STS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHIC PROCEDURES OR INTERVENTIONAL PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHE

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