American Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for American Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2183959
FEI Number1000116179
NameAmerican Medical Systems, Inc.
Owner & OperatorBoston Scientific Corporation
Contact Address300 Boston Scientific Way
Marlborough MA 01752 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10700 BREN ROAD WEST
Minnetonka, MN 55343 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR RTE Kit 2019-10-11
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Rear Tip Extender 2019-06-05
AMERICAN MEDICAL SYSTEMS, INC.
Sizer 2019-05-07
AMERICAN MEDICAL SYSTEMS, INC.
Sizer 2019-05-07
AMERICAN MEDICAL SYSTEMS, INC.
Sizer 2019-05-07
AMERICAN MEDICAL SYSTEMS, INC.
AdVance 2019-04-23
AMERICAN MEDICAL SYSTEMS, INC.
AdVance 2019-04-23
AMERICAN MEDICAL SYSTEMS, INC.
AdVance 2019-04-23
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-04
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-04
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-04
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-04
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 LGX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 LGX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 LGX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 LGX MS Pump 2019-04-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
MS Pump 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CX 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 Spherical Reservoir 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 Spherical Reservoir 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 Spherical Reservoir 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 Spherical Reservoir 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Proximal Tool 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 CXR RTE Kit 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor RTE Kit 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 700 Accessory Kit 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS Ambicor 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Quick Connect Assembly Tool 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Closing Tool 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Deactivation Package 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS 800 Artificial Urinary Sphincter 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Insertion Package 2019-02-13
AMERICAN MEDICAL SYSTEMS, INC.
Furlow Insertion Tool 2019-02-13
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 800 without Inhibizone2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 800 with Inhibizone2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
Ambicor2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 700 without Inhibizone2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 700 with Inhibizone2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
Ambicor2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 700 without Inhibizone2015-10-06
American Medical Systems, Inc. [Boston Scientific Corporation]
AMS 700 with Inhibizone2015-10-06
AMERICAN MEDICAL SYSTEMS, INC.
RETROARC RETROPUBIC SLING SYSTEM2013-11-20
AMERICAN MEDICAL SYSTEMS, INC.
AMS ELEVATE PC2011-10-25
AMERICAN MEDICAL SYSTEMS, INC.
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 7201912010-06-07
AMERICAN MEDICAL SYSTEMS, INC.
GREENLIGHT XPS LASER SYSTEM2009-11-09
AMERICAN MEDICAL SYSTEMS, INC.
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM2009-06-02
AMERICAN MEDICAL SYSTEMS, INC.
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2009-04-09
AMERICAN MEDICAL SYSTEMS, INC.
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP2009-04-02
AMERICAN MEDICAL SYSTEMS, INC.
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE2008-12-23
AMERICAN MEDICAL SYSTEMS, INC.
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE2008-11-26
AMERICAN MEDICAL SYSTEMS, INC.
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2008-10-20
AMERICAN MEDICAL SYSTEMS, INC.
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS2008-09-17
AMERICAN MEDICAL SYSTEMS, INC.
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM2008-04-10
AMERICAN MEDICAL SYSTEMS, INC.
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X082008-04-10
AMERICAN MEDICAL SYSTEMS, INC.
AMS MINIARC SLING SYSTEM2008-01-30
AMERICAN MEDICAL SYSTEMS, INC.
AMS MINIARC SLING SYSTEM2007-08-24
AMERICAN MEDICAL SYSTEMS, INC.
TOPAS SYSTEM2007-05-09
AMERICAN MEDICAL SYSTEMS, INC.
AMS SINGLE INCISION SLING SYSTEM (SIS-0)2007-03-01
AMERICAN MEDICAL SYSTEMS, INC.
AMS SMART SLING SYSTEM2007-02-22
AMERICAN MEDICAL SYSTEMS, INC.
AMS MALE TRANSOBTURATOR SLING SYSTEM2006-02-03
AMERICAN MEDICAL SYSTEMS, INC.
AMS PELVIC FLOOR REPAIR SYSTEM2005-08-03
AMERICAN MEDICAL SYSTEMS, INC.
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.2005-07-08
AMERICAN MEDICAL SYSTEMS, INC.
AMS COLLAGEN DERMAL MATRIX2005-06-17
AMERICAN MEDICAL SYSTEMS, INC.
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 724033042004-12-14
AMERICAN MEDICAL SYSTEMS, INC.
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS2004-08-11
AMERICAN MEDICAL SYSTEMS, INC.
AMS PERIGEE SYSTEM2004-05-17
AMERICAN MEDICAL SYSTEMS, INC.
AMS APOGEE VAULT SUSPENSION SYSTEM2004-04-22
AMERICAN MEDICAL SYSTEMS, INC.
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH2004-03-24
AMERICAN MEDICAL SYSTEMS, INC.
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 724039962004-03-17
AMERICAN MEDICAL SYSTEMS, INC.
AMS LARGE PORE POLYPROPYLENE MESH2003-12-31
AMERICAN MEDICAL SYSTEMS, INC.
BIOARC SP SLING KIT2003-02-06
AMERICAN MEDICAL SYSTEMS, INC.
MONARC SLING SYSTEM2002-11-19
AMERICAN MEDICAL SYSTEMS, INC.
MODIFICATION TO SPARC SLING SYSTEM2002-05-15
AMERICAN MEDICAL SYSTEMS, INC.
MODIFICATION TO SPARC SLING SYSTEM2002-03-28
AMERICAN MEDICAL SYSTEMS, INC.
SPARC SLING SYSTEM2001-10-26
AMERICAN MEDICAL SYSTEMS, INC.
AMS SOFT-TISSUE APPROXIMATION SYSTEM2001-09-05
AMERICAN MEDICAL SYSTEMS, INC.
SPARC SLING SYSTEM2001-08-01
AMERICAN MEDICAL SYSTEMS, INC.
IN-FAST BONE SCREW SYSTEM2001-07-13
AMERICAN MEDICAL SYSTEMS, INC.
AMS SLING FIXATION SYSTEM2001-06-22
AMERICAN MEDICAL SYSTEMS, INC.
AMS SACRAL COLPOPEXY SLING, MODEL 724035012001-04-09
AMERICAN MEDICAL SYSTEMS, INC.
AMS FASCIAL-ANCHORING SYSTEM2001-03-26
AMERICAN MEDICAL SYSTEMS, INC.
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH2000-11-29
AMERICAN MEDICAL SYSTEMS, INC.
STAPLETAC2 BONE ANCHOR SYSTEM2000-03-01
AMERICAN MEDICAL SYSTEMS, INC.
COAGULOOP1999-06-29
AMERICAN MEDICAL SYSTEMS, INC.
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS1998-12-23
AMERICAN MEDICAL SYSTEMS, INC.
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS1998-01-09
AMERICAN MEDICAL SYSTEMS, INC.
AMS FOREIGN BODY EXTRATOR1997-08-29
AMERICAN MEDICAL SYSTEMS, INC.
AMS COAGULOOP RESECTION ELECTRODE1997-07-24
AMERICAN MEDICAL SYSTEMS, INC.
AMS MAINSTAY UROLOGIC BONE ANCHOR1997-07-09
AMERICAN MEDICAL SYSTEMS, INC.
AMS AMBICOR PENILE PROSTHESIS1996-12-04
AMERICAN MEDICAL SYSTEMS, INC.
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS1995-12-27
AMERICAN MEDICAL SYSTEMS, INC.
AMS 650 MALLERABLE PENIEL PROSTHESIS1995-07-06
AMERICAN MEDICAL SYSTEMS, INC.
ENTRAC URETERAL BALLOON DILATATION CATHETERS1994-08-19
AMERICAN MEDICAL SYSTEMS, INC.
NAMIC ARIA(TM) INFLATION DEVICE1994-04-18
AMERICAN MEDICAL SYSTEMS, INC.
ENTRAC URETERAL BALLOON DILATION CATHETERS1992-10-28
AMERICAN MEDICAL SYSTEMS, INC.
120 FR OPTILUME PROSTATE BALLOON DILATOR1992-10-28
AMERICAN MEDICAL SYSTEMS, INC.
ENTRAC URETHRAL BALLOON DILATATION CATHETER1992-05-06
AMERICAN MEDICAL SYSTEMS, INC.
ENTRAC(TM) URETHRAL MEASURING CATHETER1992-03-20
AMERICAN MEDICAL SYSTEMS, INC.
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS1992-03-18
AMERICAN MEDICAL SYSTEMS, INC.
AMS SPHINCTER 800 URINARY PROSTHESIS1992-03-18
AMERICAN MEDICAL SYSTEMS, INC.
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER1990-06-27
AMERICAN MEDICAL SYSTEMS, INC.
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR1990-05-17
AMERICAN MEDICAL SYSTEMS, INC.
AMS OPTILUME INFLATION SYRINGE1990-05-17
AMERICAN MEDICAL SYSTEMS, INC.
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS1990-03-06
AMERICAN MEDICAL SYSTEMS, INC.
1/2 CM REAR TIP EXTENDER (RTE)1988-06-17
AMERICAN MEDICAL SYSTEMS, INC.
URETERAL STENT1985-09-05
AMERICAN MEDICAL SYSTEMS, INC.
VERIFORM II1984-01-30
AMERICAN MEDICAL SYSTEMS, INC.
AMS MALLEABLE PENILE PROSTHESIS1983-08-08
AMERICAN MEDICAL SYSTEMS, INC.
INFLATABLE PENILE PROSTH. - CYLINDER1983-04-12
AMERICAN MEDICAL SYSTEMS, INC.
THE INFLATABLE PENILE PROSTHESIS1982-08-10
AMERICAN MEDICAL SYSTEMS, INC.
THE ARTIFICIAL URINARY SPHINCTER1982-08-10
AMERICAN MEDICAL SYSTEMS, INC.
TOMAC LUBRICATING JELLY1982-07-30
AMERICAN MEDICAL SYSTEMS, INC.
THERMO-K1982-04-29
AMERICAN MEDICAL SYSTEMS, INC.
AMS MALLEABLE OR JONAS SILICONE-SILVER1980-09-09
AMERICAN MEDICAL SYSTEMS, INC.
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-21979-05-14

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