PMA supplement

P800069 S002: THE AMCON WAY PLUS

FDA PMA supplement · Amcon, Inc.

Key facts

Original PMA P800069
Supplement number S002
Trade name THE AMCON WAY PLUS
Generic name Accessories, soft lens products
Applicant Amcon, Inc.
Product code LPN
Received date May 12, 1982
Decision date Oct 5, 1982
Notice date Feb 22, 1983

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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