American Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 72 products

Total Devices72

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K132655	RETROARC RETROPUBIC SLING SYSTEM	OTN	2013-11-20	View
510(k)	K112842	AMS ELEVATE PC	OTP	2011-10-25	View
510(k)	K100807	MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191	PAH	2010-06-07	View
510(k)	K092735	GREENLIGHT XPS LASER SYSTEM	GEX	2009-11-09	View
510(k)	K090934	PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM	FTL	2009-06-02	View
510(k)	K090663	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	FAE	2009-04-09	View
510(k)	K090713	ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP	OTP	2009-04-02	View
510(k)	K082677	AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	OTP	2008-12-23	View
510(k)	K082730	AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE	OTP	2008-11-26	View
510(k)	K082006	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	FAE	2008-10-20	View
510(k)	K081613	SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS	OTN	2008-09-17	View
510(k)	K080185	AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM	OTP	2008-04-10	View
510(k)	K073219	WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08	FTM	2008-04-10	View
510(k)	K073703	AMS MINIARC SLING SYSTEM	PAH	2008-01-30	View
510(k)	K071902	AMS MINIARC SLING SYSTEM	PAH	2007-08-24	View
510(k)	K070993	TOPAS SYSTEM	FTL	2007-05-09	View
510(k)	K070065	AMS SINGLE INCISION SLING SYSTEM (SIS-0)	PAH	2007-03-01	View
510(k)	K063713	AMS SMART SLING SYSTEM	OTN	2007-02-22	View
510(k)	K053371	AMS MALE TRANSOBTURATOR SLING SYSTEM	OTM	2006-02-03	View
510(k)	K051485	AMS PELVIC FLOOR REPAIR SYSTEM	OTO	2005-08-03	View