PMA supplement

P870007 S003: SORBIC ACID PRESERVED SALINE SOLUTION

FDA PMA supplement · Special (Immediate Track) · Optopics Laboratories Corp.

Key facts

Original PMA P870007
Supplement number S003
Supplement type Special (Immediate Track)
Reason for the supplement Change Design/Components/Specifications/Material
Trade name SORBIC ACID PRESERVED SALINE SOLUTION
Generic name Accessories, soft lens products
Applicant Optopics Laboratories Corp.
Product code LPN
Received date May 11, 1990
Decision date Jun 7, 1990

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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