PMA supplement

P800055 S002: THE NORMALINE KIT

FDA PMA supplement · Apothecary Products, Inc.

Key facts

Original PMA P800055
Supplement number S002
Trade name THE NORMALINE KIT
Generic name Accessories, soft lens products
Applicant Apothecary Products, Inc.
Product code LPN
Received date Sep 15, 1982
Decision date May 27, 1983
Notice date Jun 17, 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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