PMA supplement

P810017 S011: SOFT MATE WEEKLY CLEANING SOLUTION

FDA PMA supplement · THIRTY DAY TRACK · Advanced Medical Optics, Inc.

Key facts

Original PMA P810017
Supplement number S011
Supplement type THIRTY DAY TRACK
Reason for the supplement Other
Trade name SOFT MATE WEEKLY CLEANING SOLUTION
Generic name Accessories, soft lens products
Applicant Advanced Medical Optics, Inc.
Product code LPN
Received date Nov 6, 1986
Decision date Dec 1, 1986

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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