PMA supplement

P870017 S002: VIS-SOL STERILE PRESERVED SALINE SOLUTION

FDA PMA supplement · Normal 180 Day Track · Visioncare Assoc.

Key facts

Original PMA P870017
Supplement number S002
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name VIS-SOL STERILE PRESERVED SALINE SOLUTION
Generic name Accessories, soft lens products
Applicant Visioncare Assoc.
Product code LPN
Received date Jan 10, 1990
Decision date Jul 5, 1990

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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