Product code PAG

Device name: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.3300
Review panel: GU
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K090688	COOK UROLOGICAL GRAFT	Cook Biotech, Inc.	2009-07-10
K050445	AMS COLLAGEN DERMAL MATRIX	American Medical Systems, Inc.	2005-06-17
K042949	PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)	C.R. Bard, Inc.	2004-11-09
K031295	BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM	C.R. Bard, Inc.	2003-05-15
K030460	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Brennen Medical, Inc.	2003-03-07
K020654	STRATASIS SLING KIT	Cook Biotech, Inc.	2002-04-09
K993459	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Advanced Uroscience, Inc.	1999-11-05
K992159	SURGISIS SLING	Cook Biotech, Inc.	1999-09-23
K982403	BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Brennen Medical, Inc.	1998-09-22

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00812337020671	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2025-03-14
00812337020688	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2025-03-14
00812337025300	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
00812337025317	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
00812337025324	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
00812337025331	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
00812337025348	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
00812337025355	Meso BioMatrix® Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2017-12-08
M26330051010	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15
M26330051020	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15
M26330051030	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15
M26330051040	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15
M26330051050	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15
M26330051060	Meso BioMatrix™ Acellular Peritoneum Matrix	DSM BIOMEDICAL, INC.	2015-09-15

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