PMA supplement

P820026 S002: METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT

FDA PMA supplement · Metrosoft, Inc.

Key facts

Original PMA P820026
Supplement number S002
Trade name METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT
Generic name Lenses, soft contact, daily wear
Applicant Metrosoft, Inc.
Product code LPL
Received date Sep 24, 1985
Decision date Apr 13, 1988

At a glance

  • No Expedited review granted
  • No Approval order on file
  • No Summary of safety and effectiveness on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA supplements

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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