510(k) K051485

AMS PELVIC FLOOR REPAIR SYSTEM by American Medical Systems, Inc. — Product Code OTO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 3, 2005
Date Received: June 6, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class: Class II
Regulation Number: 878.3300
Review Panel: OB
Submission Type

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

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 OTO

K171271 — Polyform Synthetic Mesh (December 15, 2017)
K150016 — Vertessa Lite (April 6, 2015)
K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
K140116 — RESTORELLE Y CONTOUR MESH (February 12, 2014)
K132061 — RESTORELLE M, RESTORELLE XL (August 2, 2013)
K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (April 25, 2013)
K123914 — RESTORELLE Y CONTOUR (March 5, 2013)
K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (February 21, 2013)
K122794 — UPSYLON Y MESH (December 18, 2012)
K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)