ProStar™ XL Percutaneous Vascular Surgical System offers percutaneous surgical repair of femoral artery access sites 8.5-10F. Other features of the Prostar™ XL PVS System:
Prostar™ XL Percutaneous Vascular Surgical System |
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Designed for use in 8.5-10F femoral artery access sites following catheterization procedures. |
Product Code / Catalog # 12322-01 |
Sold 5 systems per box |
Included in Prostar™ XL System Package: 1 Prostar™ XL Device, 1 Knot Pusher |
Data on file at Abbott.
*Prostar™ XL Percutaneous Vascular Surgical System - Instructions for Use (IFU). Refer to IFU for additional information.
MAT-2207294 v1.0
The Prostar™ XL PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS sections).
None known.
The outer pouch of the Prostar™ XL PVS System and the individual accessories provides the sterile barrier. Do not use the Prostar™ PVS System or accessories if the packaging or sterile barrier have been previously opened or damaged, or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The Prostar™ XL PVS System and accessories are intended for single use only.
Do not use the Prostar™ XL PVS System if the puncture site is proximal to the inguinal ligament as this may
The following adverse events have been reported and may occur include:
MAT-2114591 v2.0
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Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
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