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American Medical Systems

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131229 SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMSOTN2013-12-05 View
510(k) K121805 AMS LARGE PORE POLYPROPHLENE MESHOTO2012-10-16 View
510(k) K121641 MINIARC PRO SINGLE-INCISION SLING SYSTEMPAH2012-09-07 View
510(k) K121612 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONOTP2012-07-20 View
510(k) K120870 GREENLIGHT MOXY FIBER OPTICGEX2012-06-15 View
510(k) K111118 AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITEOTP2011-07-01 View
510(k) K100746 FIBER ONEGEX2010-06-11 View
510(k) K082387 APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEMOTP2008-12-04 View
510(k) K081710 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITEOTP2008-10-15 View
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