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510(k) K050445

AMS COLLAGEN DERMAL MATRIX by American Medical Systems, Inc. — Product Code PAG

K050445 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS COLLAGEN DERMAL MATRIX". The FDA issued a decision of Substantially Equivalent on June 17, 2005. The device falls under product code PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator), a Class II device regulated under 21 CFR 878.3300. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2005
Date Received
February 22, 2005
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.

Other clearances by American Medical Systems, Inc.

  • K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS (June 20, 2014)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)
  • K132655 — RETROARC RETROPUBIC SLING SYSTEM (November 20, 2013)
  • K121805 — AMS LARGE PORE POLYPROPHLENE MESH (October 16, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 2012)
  • K120870 — GREENLIGHT MOXY FIBER OPTIC (June 15, 2012)
  • K112842 — AMS ELEVATE PC (October 25, 2011)
  • K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
  • K100746 — FIBER ONE (June 11, 2010)

Other clearances for product code PAG

  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K042949 — PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) (November 9, 2004)
  • 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)

FDA data resources