PMA supplement

P800060 S001: THE SOFT RINSE SYSTEM

FDA PMA supplement · Dow Corning Corp. Healthcare Industries Materials

Key facts

Original PMA P800060
Supplement number S001
Trade name THE SOFT RINSE SYSTEM
Generic name Accessories, soft lens products
Applicant Dow Corning Corp. Healthcare Industries Materials
Product code LPN
Received date Jan 15, 1982
Decision date Feb 5, 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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