FDA 510(k) Applications for Medical Device Product Code: OTP ()

FDA 510(k) Applications for Medical Device Product Code "OTP"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K111118	AMERICAN MEDICAL SYSTEMS	AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	07/01/2011
K082387	AMERICAN MEDICAL SYSTEMS	APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM	12/04/2008
K081710	AMERICAN MEDICAL SYSTEMS	APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE	10/15/2008
K121612	AMERICAN MEDICAL SYSTEMS	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION	07/20/2012
K040537	AMERICAN MEDICAL SYSTEMS, INC.	AMS APOGEE VAULT SUSPENSION SYSTEM	04/22/2004
K082677	AMERICAN MEDICAL SYSTEMS, INC.	AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	12/23/2008
K082730	AMERICAN MEDICAL SYSTEMS, INC.	AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE	11/26/2008
K112842	AMERICAN MEDICAL SYSTEMS, INC.	AMS ELEVATE PC	10/25/2011
K080185	AMERICAN MEDICAL SYSTEMS, INC.	AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM	04/10/2008
K033636	AMERICAN MEDICAL SYSTEMS, INC.	AMS LARGE PORE POLYPROPYLENE MESH	12/31/2003
K040623	AMERICAN MEDICAL SYSTEMS, INC.	AMS PERIGEE SYSTEM	05/17/2004
K090713	AMERICAN MEDICAL SYSTEMS, INC.	ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP	04/02/2009
K040521	AMERICAN MEDICAL SYSTEMS, INC.	MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH	03/24/2004
K103426	BOSTON SCIENTIFIC CORP.	LITE PELVIC FLOOR REPAIR KITS	09/14/2011
K081048	BOSTON SCIENTIFIC CORP.	PINNACLE PELVIC FLOOR REPAIR KIT II	08/22/2008
K071957	BOSTON SCIENTIFIC CORP.	PINNACLE PELVIC FLOOR REPAIR KITS	11/08/2007
K122459	Boston Scientific Corporation	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM	12/13/2012
K091131	BOSTONSCIENTIFIC	PELVIC FLOOR REPAIR SYSTEM	05/08/2009
K083839	C.R. BARD, INC.	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM	01/15/2009
K082571	C.R. BARD, INC.	AVAULTA SUPPORT SYSTEM	09/30/2008
K063712	C.R. BARD, INC.	AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM	03/12/2007
K083722	CALDERA MEDICAL, INC.	ASCEND	03/31/2009
K083499	COLOPLAST A/S	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	05/08/2009
K112386	COLOPLAST CORP.	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM	09/08/2011
K071512	ETHICON, INC.	GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS	05/15/2008
K063562	ETHICON, INC.	GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS	02/26/2007
K053414	MENTOR CORP.	MENTOR NOVASILK MESH	12/27/2005
K092207	MPATHY MEDICAL DEVICES INC	RESTORELLE POLYPROPYLENE MESH	08/04/2009
K102815	NEOMEDIC INTERNATIONAL	SURELIFT PROLAPSE SYSTEM	07/07/2011
K072951	SOFRADIM PRODUCTION	PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES	12/19/2007
K051503	SOFRADIM PRODUCTION	UGYTEX SUAL KNIT MESH	08/05/2005