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Avitene Microfibibrillar Collagen Hemostat Products- Non-Woven Web, Ultrafoam, …

FDA PMA

Class III (US FDA PMA)

PMA P800002

by C. R. Bard, Inc.

Identity

Trade Name
AVITENE(R) NON-WOVEN WEB FDA PMA
Generic Name
Agent, absorbable hemostatic, collagen based FDA PMA

Identifiers

PMA Number
P800002 FDA PMA
FDA Product Code
LMF FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 878.4490 FDA PMA
Regulation Number
878.4490 FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S001 FDA PMA

Avitene Microfibrillar Collagen Hemostat Products are absorbable hemostatic agents made from collagen, designed to control bleeding during surgical procedures. The product is supplied as a non-woven web, ultrafoam, or flour formulation in a 1G syringe for endoscopic application.

It is intended for use in general and plastic surgery settings as a topical hemostat. The device is sterile, single-use, and supplied in a syringe format for precise delivery. Regulatory authorization is via FDA PMA (P800002, supplement S001), with product code LMF and classification under regulation 878.4490 as a Class III device.

Frequently asked questions

What is the generic name of this device?

The generic name is Agent, absorbable hemostatic, collagen based, as specified in the device data under the openfda field.

Who manufactures this device and where is it located?

The device is manufactured by C. R. Bard, Inc., located at 160 New Boston St., Woburn, MA 01801, as stated in the manufacturer and address fields.

What regulatory pathway was used for this device's authorization?

The device received authorization via FDA Premarket Approval (PMA), with PMA number P800002 and supplement number S001, as indicated in the AUTHORIZATIONS and pma_number fields.

This description and any FAQs above were generated automatically from registry data 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA PMA P800002 24 fields · synced Sep 18, 2026