PMA supplement

N16993 S003: ADSORBOTEAR(R)

FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories

Key facts

Original PMA N16993
Supplement number S003
Supplement type Normal 180 Day Track
Trade name ADSORBOTEAR(R)
Generic name Accessories, soft lens products
Applicant Alcon Laboratories
Product code LPN
Received date Feb 2, 1980
Decision date Mar 15, 1982

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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