PMA supplement

P800026 S010: PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO

FDA PMA supplement · Special (Immediate Track) · Alcon Laboratories

Key facts

Original PMA P800026
Supplement number S010
Supplement type Special (Immediate Track)
Reason for the supplement Labeling Change - Indications/instructions/shelf life/tradename
Trade name PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO
Generic name Accessories, soft lens products
Applicant Alcon Laboratories
Product code LPN
Received date Aug 26, 1994
Decision date Dec 13, 1994

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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