PMA supplement

P820061 S001: PARAPERM O2 CONTACT LENS CLEAR & BLUE

FDA PMA supplement · Dupont Legal

Key facts

Original PMA P820061
Supplement number S001
Trade name PARAPERM O2 CONTACT LENS CLEAR & BLUE
Generic name Lens, contact (polymethylmethacrylate)
Applicant Dupont Legal
Product code HPX
Received date Jul 31, 1984
Decision date Dec 6, 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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