PMA supplement

P820017 S005: HYDRACON(R) CONTACT LENSES

FDA PMA supplement · Hydracon

Key facts

Original PMA P820017
Supplement number S005
Trade name HYDRACON(R) CONTACT LENSES
Generic name Lenses, soft contact, daily wear
Applicant Hydracon
Product code LPL
Received date Mar 14, 1983
Decision date Apr 28, 1983

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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