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510(k) K122459

PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM by Boston Scientific Corporation — Product Code OTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
August 13, 2012
Clearance Type
Abbreviated
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

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Other clearances for product code OTP

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  • 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)
  • K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K091131 — PELVIC FLOOR REPAIR SYSTEM (May 8, 2009)
  • K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (May 8, 2009)
  • K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR (April 2, 2009)