
American Medical Systems, Inc.
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MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 is an FDA 510(k)-cleared medical device (K100807) manufactured by American Medical Systems, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2010. Regulation: 8.