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Lea's Shield Barrier Contraceptive

by Yama, Inc. PMA

Active United States

PMA P010043

Overview

Lea's Shield Barrier Contraceptive is a cervical cap contraceptive device indicated for use by women of childbearing age who desire to prevent or postpone pregnancy. It is classified as a Class III medical device under FDA regulations.

The device is supplied as a reusable barrier contraceptive and is authorized under FDA PMA P010043. It is intended for use in obstetrics and gynecology settings and is not MRI conditional unless explicitly stated in the labeling.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP010043 Date14 Mar 2002ApprovedStatusActive

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 6 Oct 2026.

Specification

PMA

Generic Name
Cap, cervical, contraceptive
PMA Number
FDA Product Code
LLQ
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APPR Approved

Questions

  • What is the Lea's Shield Barrier Contraceptive used for?

    The Lea's Shield Barrier Contraceptive is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy, as stated in the approval documentation.

  • Who manufactures the Lea's Shield Barrier Contraceptive?

    The Lea's Shield Barrier Contraceptive is manufactured by Yama, Inc., located in Millburn, New Jersey.

  • Is the Lea's Shield Barrier Contraceptive a single-use or reusable device?

    The Lea's Shield Barrier Contraceptive is a reusable barrier contraceptive device, as indicated by its classification and intended use for repeated application.