PMA supplement

P810001 S002: MODEL AC (AC1-AC5)

FDA PMA supplement · Alcon

Key facts

Original PMA P810001
Supplement number S002
Trade name MODEL AC (AC1-AC5)
Generic name Intraocular lens
Applicant Alcon
Product code HQL
Received date Jul 12, 1983
Decision date Apr 12, 1985

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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