PMA supplement

P850055 S002: MIRAFLOW EXTRA STRENGTH CLEANER

FDA PMA supplement · Normal 180 Day Track · Ciba Vision Corporation

Key facts

Original PMA P850055
Supplement number S002
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name MIRAFLOW EXTRA STRENGTH CLEANER
Generic name Accessories, soft lens products
Applicant Ciba Vision Corporation
Product code LPN
Received date Mar 3, 1988
Decision date May 5, 1988

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:

Browse all PMA supplements