
American Medical Systems, Inc.
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AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS is an FDA 510(k)-cleared medical device (K896941) manufactured by American Medical Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 1990. Regulation: 8.