PMA supplement

N18032 S005: CABCURVE (POROFOCAN B)

FDA PMA supplement · Wesley Jessen Corp.

Key facts

Original PMA N18032
Supplement number S005
Trade name CABCURVE (POROFOCAN B)
Generic name Lens, contact (polymethylmethacrylate)
Applicant Wesley Jessen Corp.
Product code HPX
Received date Aug 25, 1982
Decision date Feb 10, 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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