PMA supplement

P820040 S003: SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

FDA PMA supplement · Ciba Vision Care

Key facts

Original PMA P820040
Supplement number S003
Trade name SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH
Generic name Accessories, soft lens products
Applicant Ciba Vision Care
Product code LPN
Received date Jul 17, 1984
Decision date Oct 4, 1985

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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