PMA supplement

P810032 S057: PMMA INTRAOCULAR LENSES

FDA PMA supplement · 30-Day Notice · Alcon Laboratories

Key facts

Original PMA P810032
Supplement number S057
Supplement type 30-Day Notice
Trade name PMMA INTRAOCULAR LENSES
Generic name Intraocular lens
Applicant Alcon Laboratories
Product code HQL
Received date May 3, 2010
Decision date Jun 2, 2010

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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