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Absorbable Surgical Suture, USP

by Ethicon Inc. 3 variants

PMA N15405

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N15405

FDA record

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN15405 Date20 Jun 1986ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade name
Collagen Suture (Plain!chromic) Absorbable
Generic name
Suture, absorbable, natural
FDA applicant
ETHICON, Inc.
PMA number
FDA product code
GAL
Device class
Class II
Regulation
21 CFR Part 878.4830
Advisory committee
General, Plastic Surgery
FDA decision
APPR Approved
PMA supplement
S006

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an absorbable surgical suture classified as a natural absorbable suture, designed for internal and external wound closure. It is manufactured from materials that gradually dissolve within the body after serving its purpose, eliminating the need for suture removal.

The suture is supplied in sterile form for single-use applications and is intended for use in general and plastic surgery procedures. It is regulated under FDA Premarket Approval (PMA) and falls under classification GAL (General and Plastic Surgery). Various sizes and lengths are available, adhering to USP standards for absorbable sutures.

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