PMA supplement

P780007 S004: HYDRON SEMI SCLERAL, MINI, TORIC

FDA PMA supplement · CooperVision, Inc.

Key facts

Original PMA P780007
Supplement number S004
Trade name HYDRON SEMI SCLERAL, MINI, TORIC
Generic name Lenses, soft contact, daily wear
Applicant CooperVision, Inc.
Product code LPL
Received date Nov 19, 1979
Decision date Mar 18, 1980

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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