Manufacturer

Product Name (Device)

Number of MAUDE Events

Date Range

American Medical Systems

SPARC

65

02/21/2002 to 06/21/2007

Bard

Pelvicol

64

10/15/2001 to 05/08/2008

Pelvisoft

1

Boston Scientific Scimed

Prefyx PPS

23

08/11/2006 to 9/3/2008

Obtryx Curved Single

1

On 01/10/2006

Obtryx Mesh Sling

62

08/24/2005 to 09/18/2008

Advantage Sling System

29

07/25/2006 to 09/19/2008

Prefyx System Mid U

23

08/11/2006 to 09/03/2008

Mesh Sling System

78

08/19/2004 to 09/18/2008

Caldera

T-Sling

2

06/15/2004 to 11/26/2007

Ethicon

Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor

123

04/14/2004 to 03/02/2008

Prolene Polypropylene Mesh

72

01/28/2002 to 09/18/2008

Gynecare

Secur

1

Single Report on October 4, 2007

TVT (See Ethicon, Inc. and Johnson & Johnson) (K974098)

4

07/21/2003 to 10/04/2007

Johnson & Johnson

Tension-Free Vaginal Tape (K974098) Also Medscand Medical Lab (Sweden), Ethicon, Inc., Ethicon Sarl (Switzerland),

495

05/12/1999 to 02/27/2007

Mentor

ObTape (K031767)

236

11/01/2002 to 10/19/2007

Sofradim

Uretex TO

64

10/23/2002 to 05/08/2008

Avaulta Biosynthetic

0

Uretex Pubovaginal Sling/support kit

27

10/24/2002 to 04/22/2008

Bard Posterior Biosynthetic Support System

3

06/14/2007 to 09/14/2007

Pelvetex Polypropylene Mesh

0