PMA supplement

P820040 S026: SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

FDA PMA supplement · Normal 180 Day Track · Ciba Vision Care

Key facts

Original PMA P820040
Supplement number S026
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH
Generic name Accessories, soft lens products
Applicant Ciba Vision Care
Product code LPN
Received date Mar 2, 1990
Decision date Aug 8, 1991

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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