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AMS800 Artificial Urinary Sphincter - ARCSA Registration 92b246c8955eb10f868ff73c14fd7873

Access comprehensive regulatory information for AMS800 Artificial Urinary Sphincter in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 92b246c8955eb10f868ff73c14fd7873 and manufactured by BOSTON SCIENTIFIC CORPORATION. The device was registered on August 22, 2023.

This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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III
92b246c8955eb10f868ff73c14fd7873
AMS800 Artificial Urinary Sphincter
ARCSA ID: 92b246c8955eb10f868ff73c14fd7873
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Device Classification
Risk Class
III
Product Type
Invasive
Brand Name
Boston Scientific, AMS 800™, AMS800 withInhibiZone™
Commercial Name
PROTESIS, ESFINTER DE LA URETRA
Registration Information
Analysis ID
92b246c8955eb10f868ff73c14fd7873
Registration Date
August 22, 2023
Expiration Date
August 22, 2028
Product Use

AMS 800 ARTIFICIAL URINARY SPHINCTER IS INDICATED FOR THE TREATMENT OF URINARY INCONTINENCE DUE TO REDUCED URETHRA/BLADDER OUTFLOW RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) IN MEN AND WOMEN.

Manufacturer
Country
UNITED STATES
Address
4100 HAMLINE AVE. N.,ST. PAUL, MINNESOTA, 55112,USA
Product Owner
Name
BOSTON SCIENTIFIC CORPORATION
Country
UNITED STATES
Authorized Representative
Address
THE SN TELEGRAPH AND LATEST NEWS
Phone
2520070