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510(k) K042949

PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) by C.R. Bard, Inc. — Product Code PAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2004
Date Received
October 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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  • K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PT (May 4, 2022)
  • K212708 — Halo One Thin-Walled Guiding Sheath (September 23, 2021)

Other clearances for product code PAG

  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K050445 — AMS COLLAGEN DERMAL MATRIX (June 17, 2005)
  • K031295 — BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM (May 15, 2003)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K020654 — STRATASIS SLING KIT (April 9, 2002)
  • K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (November 5, 1999)
  • K992159 — SURGISIS SLING (September 23, 1999)
  • K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (September 22, 1998)