PMA supplement

N17974 S042: PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES

FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories

Key facts

Original PMA N17974
Supplement number S042
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES
Generic name Accessories, soft lens products
Applicant Alcon Laboratories
Product code LPN
Received date Oct 25, 1987
Decision date Dec 13, 1988

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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