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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K121641	AMERICAN MEDICAL SYSTEMS	MINIARC PRO SINGLE-INCISION SLING SYSTEM	09/07/2012
K071902	AMERICAN MEDICAL SYSTEMS, INC.	AMS MINIARC SLING SYSTEM	08/24/2007
K073703	AMERICAN MEDICAL SYSTEMS, INC.	AMS MINIARC SLING SYSTEM	01/30/2008
K070065	AMERICAN MEDICAL SYSTEMS, INC.	AMS SINGLE INCISION SLING SYSTEM (SIS-0)	03/01/2007
K100807	AMERICAN MEDICAL SYSTEMS, INC.	MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191	06/07/2010
K081275	BOSTON SCIENTIFIC CORP.	BOSTON SCIENTIFIC SURGICAL MESH	08/27/2008
K092607	C.R. BARD, INC.	AJUST ADJUSTABLE SINGLE INCISION SLING	11/20/2009
K123179	C.R. BARD, INC.	AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING	11/02/2012
K103418	CALDERA MEDICAL, INC.	DESARA MINI	11/30/2011
K191416	Caldera Medical, Inc.	Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack	02/07/2020
K121562	COLOPLAST A/S	ALTIS SINGLE INCISION CLING SYSTEM	11/05/2012
K221874	Coloplast A/S	Altis Single Incision Sling System	02/15/2023
K052401	ETHICON, INC.	GYNECARE TVT SECUR SYSTEM	11/28/2005
K023898	GYNE IDEAS LTD.	GYNE IDEAS MINITAPE RP DEVICE	06/18/2003
K020652	HERNIAMESH	HERNIAMESH T-SLING	05/15/2002
K073646	MPATHY MEDICAL DEVICES, LTD.	MINITAPE URETHRAL SLING	02/25/2008
K091180	MPATHY MEDICAL DEVICES, LTD.	MINITAPE URETHRAL SLING	07/14/2009
K110420	PROMEDON S.A.	OPHIRA MINI SLING SYSTEM	05/08/2012
K063136	SPECIALITIES REMEEX INTERNATIONAL, S.L.	NEEDLELESS SLING	12/19/2006