PMA supplement

N18114 S004: RX-56 POROFOCON A CONTACT LENS

FDA PMA supplement · Rynco Scientific Corp.

Key facts

Original PMA N18114
Supplement number S004
Trade name RX-56 POROFOCON A CONTACT LENS
Generic name Lens, contact (polymethylmethacrylate)
Applicant Rynco Scientific Corp.
Product code HPX
Received date Aug 19, 1980
Decision date Mar 16, 1981

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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