PMA supplement

N17951 S002: TRI POL 43 CONTACT LENS

FDA PMA supplement · Applied Optics, Inc.

Key facts

Original PMA N17951
Supplement number S002
Trade name TRI POL 43 CONTACT LENS
Generic name Lenses, soft contact, daily wear
Applicant Applied Optics, Inc.
Product code LPL
Received date Dec 26, 1978
Decision date Feb 26, 1979

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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