PMA supplement

P820026 S008: METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT

FDA PMA supplement · Normal 180 Day Track · Metrosoft, Inc.

Key facts

Original PMA P820026
Supplement number S008
Supplement type Normal 180 Day Track
Reason for the supplement Other
Trade name METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT
Generic name Lenses, soft contact, daily wear
Applicant Metrosoft, Inc.
Product code LPL
Received date Jul 23, 1990
Decision date Sep 17, 1990

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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