FDA 510(k) Applications Submitted by AMERICAN MEDICAL SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K070065 01/08/2007 AMS SINGLE INCISION SLING SYSTEM (SIS-0) AMERICAN MEDICAL SYSTEMS, INC.
K071902 07/10/2007 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K063713 12/14/2006 AMS SMART SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K073703 12/31/2007 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K092735 09/04/2009 GREENLIGHT XPS LASER SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K991314 04/16/1999 COAGULOOP AMERICAN MEDICAL SYSTEMS, INC.
K023516 10/21/2002 MONARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K040538 03/02/2004 BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 AMERICAN MEDICAL SYSTEMS, INC.
K090713 03/18/2009 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP AMERICAN MEDICAL SYSTEMS, INC.
K051530 06/09/2005 MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. AMERICAN MEDICAL SYSTEMS, INC.
K100807 03/22/2010 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 AMERICAN MEDICAL SYSTEMS, INC.
K010277 01/30/2001 AMS FASCIAL-ANCHORING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K050445 02/22/2005 AMS COLLAGEN DERMAL MATRIX AMERICAN MEDICAL SYSTEMS, INC.
K051485 06/06/2005 AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K020446 02/11/2002 MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K040521 03/01/2004 MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC.
K040537 03/02/2004 AMS APOGEE VAULT SUSPENSION SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K040623 03/09/2004 AMS PERIGEE SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K010931 03/28/2001 AMS SACRAL COLPOPEXY SLING, MODEL 72403501 AMERICAN MEDICAL SYSTEMS, INC.
K010990 04/03/2001 AMS SLING FIXATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K011910 06/19/2001 IN-FAST BONE SCREW SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K012342 07/24/2001 AMS SOFT-TISSUE APPROXIMATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K033636 11/19/2003 AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC.
K053371 12/05/2005 AMS MALE TRANSOBTURATOR SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K011251 04/24/2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K013355 10/10/2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K002721 08/31/2000 AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH AMERICAN MEDICAL SYSTEMS, INC.
K971332 04/10/1997 AMS MAINSTAY UROLOGIC BONE ANCHOR AMERICAN MEDICAL SYSTEMS, INC.
K971512 04/28/1997 AMS COAGULOOP RESECTION ELECTRODE AMERICAN MEDICAL SYSTEMS, INC.
K963328 08/23/1996 AMS AMBICOR PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.
K041948 07/20/2004 SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS AMERICAN MEDICAL SYSTEMS, INC.
K042592 09/23/2004 INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 AMERICAN MEDICAL SYSTEMS, INC.
K972091 06/04/1997 AMS FOREIGN BODY EXTRATOR AMERICAN MEDICAL SYSTEMS, INC.
K030123 01/14/2003 BIOARC SP SLING KIT AMERICAN MEDICAL SYSTEMS, INC.
K020663 03/01/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K021263 04/22/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K112842 09/29/2011 AMS ELEVATE PC AMERICAN MEDICAL SYSTEMS, INC.
K080185 01/25/2008 AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K082677 09/15/2008 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS, INC.
K082730 09/18/2008 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE AMERICAN MEDICAL SYSTEMS, INC.
K073219 11/15/2007 WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 AMERICAN MEDICAL SYSTEMS, INC.
K132655 08/26/2013 RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K090934 04/02/2009 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K070993 04/09/2007 TOPAS SYSTEM AMERICAN MEDICAL SYSTEMS, INC.
K081613 06/09/2008 SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS AMERICAN MEDICAL SYSTEMS, INC.
K090663 03/12/2009 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.
K082006 07/15/2008 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.
K000279 01/31/2000 STAPLETAC2 BONE ANCHOR SYSTEM AMERICAN MEDICAL SYSTEMS, INC.


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