PMA supplement

P790023 S001: LENSOAK

FDA PMA supplement · Abbott Medical Optics, Inc.

Key facts

Original PMA P790023
Supplement number S001
Trade name LENSOAK
Generic name Accessories, soft lens products
Applicant Abbott Medical Optics, Inc.
Product code LPN
Received date Nov 6, 1981
Decision date Mar 3, 1982

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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