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Mersilene Polyester Suture

by Ethicon Inc.

PMA N12815

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 N12815

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 NumberN12815 Date20 Jun 1986ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic name
Suture, nonabsorbable
FDA applicant
ETHICON, Inc.
PMA number
FDA product code
GAO
Device class
Class II
Regulation
21 CFR Part 878.4495
Advisory committee
General, Plastic Surgery
FDA decision
APPR Approved
PMA supplement
S020

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.

The Mersilene Polyester Suture is a nonabsorbable, braided surgical suture designed for soft tissue approximation and ligation. It is classified as a suture, nonabsorbable, and falls under the regulatory category of Class II medical devices according to the FDA’s nomenclature.

This suture is supplied in sterile form for single-use in surgical settings. It is available in various sizes, including the R832H taper point variant, and is intended for use by trained medical professionals familiar with nonabsorbable suture techniques. The device holds an FDA Premarket Approval (PMA) under PMA number N12815 and is governed by regulation number 878.4495.

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