PMA supplement

P840055 S013: SGP LENS(TM)

FDA PMA supplement · Normal 180 Day Track · The Lifestyle Co., Inc.

Key facts

Original PMA P840055
Supplement number S013
Supplement type Normal 180 Day Track
Reason for the supplement Other
Trade name SGP LENS(TM)
Generic name Lens, contact (other material) - daily
Applicant The Lifestyle Co., Inc.
Product code HQD
Received date Feb 17, 1989
Decision date Mar 17, 1989

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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