PMA supplement

P820021 S007: SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

FDA PMA supplement · Alcon Laboratories, Inc.

Key facts

Original PMA P820021
Supplement number S007
Trade name SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
Generic name Lenses, soft contact, extended wear
Applicant Alcon Laboratories, Inc.
Product code LPM
Received date Mar 4, 1986
Decision date May 21, 1986

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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