PMA supplement

N17554 S008: SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS

FDA PMA supplement · Ciba Vision Care

Key facts

Original PMA N17554
Supplement number S008
Trade name SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS
Generic name Lenses, soft contact, daily wear
Applicant Ciba Vision Care
Product code LPL
Received date Mar 18, 1986
Decision date Jun 24, 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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