PMA supplement

P820063 S006: PARAPERM O2 CONTACT LENS

FDA PMA supplement · CooperVision, Inc.

Key facts

Original PMA P820063
Supplement number S006
Trade name PARAPERM O2 CONTACT LENS
Generic name Lens, contact (polymethylmethacrylate)
Applicant CooperVision, Inc.
Product code HPX
Received date Mar 30, 1984
Decision date May 22, 1987

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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