PMA supplement

P840069 S006: CHARTER LABS SALINE SOLUTION

FDA PMA supplement · Normal 180 Day Track · Paco Pharmaceutical Services, Inc.

Key facts

Original PMA P840069
Supplement number S006
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name CHARTER LABS SALINE SOLUTION
Generic name Accessories, soft lens products
Applicant Paco Pharmaceutical Services, Inc.
Product code LPN
Received date Sep 11, 1989
Decision date Nov 7, 1989

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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