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PDS Suture (Clear)

by Ethicon Inc.

PMA N18387

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 N18387

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 NumberN18387 Date21 Jul 1982ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Pds(Tm) Suture (Clear)
Generic name
Suture, absorbable, synthetic, polyglycolic acid
FDA applicant
ETHICON, Inc.
PMA number
FDA product code
GAM
Device class
Class II
Regulation
21 CFR Part 878.4493
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, synthetic suture made from polyglycolic acid, classified under the nomenclature as a Suture, Absorbable, Synthetic, Polyglycolic Acid. It is designed for use in general and plastic surgery to approximate tissues during surgical procedures, providing temporary wound closure through natural absorption over time.

The suture is supplied in a sterile, single-use format and is intended for use in controlled clinical settings. It is non-magnetic and MRI-safe, available in various sizes as indicated by the product codes. Authorised under FDA PMA (N18387), it adheres to regulatory standards for absorbable surgical sutures, ensuring compliance with medical device regulations for tissue approximation.

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