PMA supplement

N17734 S002: ACCUSEPT DISINFECTING UNIT

FDA PMA supplement · Strieter Laboratories, Inc.

Key facts

Original PMA N17734
Supplement number S002
Trade name ACCUSEPT DISINFECTING UNIT
Generic name Lenses, soft contact, daily wear
Applicant Strieter Laboratories, Inc.
Product code LPL
Received date Jan 20, 1982
Decision date Mar 5, 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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