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Fibrel

by Mentor Corp. United States PMA

PMA P850053 Product code LMH

Overview

The Fibrel is a dermal implant designed for aesthetic use, intended to support tissue integration and contouring in soft tissue augmentation procedures. Classified as a dermal implant for aesthetic purposes, it is engineered to provide structural support and improve the appearance of skin contours, particularly in plastic surgery applications.

This device is supplied as a single-use, sterile implant and is regulated under FDA PMA (Premarket Approval) with product code LMH. It is intended for use in controlled clinical settings by qualified surgeons, adhering to standard sterile procedures. The device’s regulatory history includes a PMA decision date of February 26, 1988, with subsequent supplements, ensuring compliance with FDA requirements for Class III medical devices.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

Withdrawn since 26 Feb 1988. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP850053 Date26 Feb 1988Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA · synced 22 Oct 2026

Generic Name
Implant, dermal, for aesthetic use
PMA Number
FDA Product Code
LMH
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APWD Approval withdrawn

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P850053 24 fields · synced 22 Oct 2026