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Avitene Ultra Foam Cast Microfibrillar Collagen Hemostat Sponge

by Davol Inc., Sub. C. R. Bard, Inc. PMA

Active United States

PMA N17600

Overview

The Avitene Ultra Foam Cast Microfibrillar Collagen Hemostat (MCH) Sponge is an absorbable hemostatic agent based on collagen. It is designed to control bleeding during surgical procedures by promoting natural clot formation.

This sponge is supplied as a sterile, single-use device and is intended for use in general and plastic surgery procedures. It is not MRI compatible and should be stored according to the manufacturer's instructions. The device has received FDA PMA approval.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberN17600 Date26 Aug 1976ApprovedStatusActive

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 Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

PMA

Full name
Avitene Ultra Foam Cast Microfibrillar Collagen Hemostat (Mch) Sponge
Trade Name
Avitene (Microfibrillar Collagen Homostat)
Generic Name
Agent, absorbable hemostatic, collagen based
PMA Number
FDA Product Code
LMF
Device Class
Class III
Regulation
21 CFR Part 878.4490
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

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Questions

  • What is the Avitene Ultra Foam Cast MCH Sponge used for?

    The Avitene Ultra Foam Cast MCH Sponge is used as an absorbable hemostatic agent in surgical procedures to control bleeding. It works by promoting natural clot formation through its collagen-based composition.

  • Is the Avitene Ultra Foam Cast MCH Sponge reusable?

    No, the Avitene Ultra Foam Cast MCH Sponge is supplied as a sterile, single-use device and should not be reused. Each sponge is intended for one surgical procedure only to ensure sterility and effectiveness.

  • What regulatory approvals does the Avitene Ultra Foam Cast MCH Sponge have?

    The Avitene Ultra Foam Cast MCH Sponge has received FDA PMA (Pre-market Approval) with the product code LMF. It is authorized for use in general and plastic surgery procedures as an absorbable hemostatic agent.