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510(k) K111118

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE by American Medical Systems — Product Code OTP

K111118 is an FDA 510(k) premarket notification submitted by American Medical Systems for the device "AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE". The FDA issued a decision of Substantially Equivalent on July 1, 2011. The device falls under product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed), a Class III device regulated under 21 CFR 884.5980. American Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
April 21, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class
Class III
Regulation Number
884.5980
Review Panel
OB
Submission Type

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

Other clearances by American Medical Systems

  • 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)
  • K100746 — FIBER ONE (June 11, 2010)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)

Other clearances for product code OTP

  • K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYS (December 13, 2012)
  • K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 2012)
  • K112842 — AMS ELEVATE PC (October 25, 2011)
  • K103426 — LITE PELVIC FLOOR REPAIR KITS (September 14, 2011)
  • K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (September 8, 2011)
  • K102815 — SURELIFT PROLAPSE SYSTEM (July 7, 2011)
  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (May 8, 2009)
  • K091131 — PELVIC FLOOR REPAIR SYSTEM (May 8, 2009)
  • K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR (April 2, 2009)

FDA data resources