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510(k) K102815

SURELIFT PROLAPSE SYSTEM by Neomedic International — Product Code OTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2011
Date Received
September 28, 2010
Clearance Type
Traditional
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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  • 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)