PMA supplement

N18032 S006: CABCURVE (POROFOCAN B)

FDA PMA supplement · Wesley Jessen Corp.

Key facts

Original PMA N18032
Supplement number S006
Trade name CABCURVE (POROFOCAN B)
Generic name Lens, contact (polymethylmethacrylate)
Applicant Wesley Jessen Corp.
Product code HPX
Received date Apr 5, 1983
Decision date Oct 25, 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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