PMA supplement

N17974 S037: FLEXSOL

FDA PMA supplement · Alcon Laboratories

Key facts

Original PMA N17974
Supplement number S037
Trade name FLEXSOL
Generic name Accessories, soft lens products
Applicant Alcon Laboratories
Product code LPN
Received date Dec 14, 1983
Decision date Jun 29, 1984

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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