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ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

FDA premarket approval P930038/S019 · decided 2000-03-08

Approval details

PMA number
P930038
Supplement
S019
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Generic name
Device, hemostasis, vascular
Applicant
Terumo Medical Corporation
Date received
1999-06-28
Decision date
2000-03-08
Days to decision
254 days
Decision code
APPR
Product code
MGB
Advisory committee
Cardiovascular
Expedited review
No
Location
Elkton, MD
Statement
Approval for the 6F Angio-Seal(TM) Hemostatic Puncture Closure Device. The device, as modified, will be marketed under the trade name 6F Angio-Seal(TM) Hemostatic Puncture Closure Device and is indicated for closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a 6 French or smaller procedureal sheath. The Angio-Seal (TM) device reduces the times to hemostasis, ambulation and discharge in patients who have unde

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