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510(k) K050355

PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 by Tissue Science Laboratories, Plc — Product Code PAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2005
Date Received
February 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Non-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 and uterine prolapse repair completed transvaginally.

Other clearances by Tissue Science Laboratories, Plc

  • K053562 — ZIMMER COLLAGEN REPAIR PATCH (June 23, 2006)
  • K043366 — PERMACOL SURGICAL IMPLANT (December 17, 2004)
  • K021056 — PERMACOL (October 31, 2002)
  • K013625 — PERMACOL (January 17, 2002)
  • K992556 — PERMACOL (February 17, 2000)

Other clearances for product code PAI

  • K130006 — BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (April 5, 2013)