PMA supplement

N18078 S008: PRESERVATIVE-FREE SOFT LENS RINSE

FDA PMA supplement · Advanced Medical Optics, Inc.

Key facts

Original PMA N18078
Supplement number S008
Trade name PRESERVATIVE-FREE SOFT LENS RINSE
Generic name Accessories, soft lens products
Applicant Advanced Medical Optics, Inc.
Product code LPN
Received date Apr 28, 1983
Decision date Aug 4, 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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