PMA supplement

P930014 S001: NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES

FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories, Inc.

Key facts

Original PMA P930014
Supplement number S001
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
Generic name Intraocular lens
Applicant Alcon Laboratories, Inc.
Product code HQL
Received date Jan 31, 1995
Decision date Jul 24, 1995

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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