PMA supplement

P820070 S012: BOSTON LENS(R) CONDITIONING SOLUTION

FDA PMA supplement · Special (Immediate Track) · Polymer Technology Corp.

Key facts

Original PMA P820070
Supplement number S012
Supplement type Special (Immediate Track)
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name BOSTON LENS(R) CONDITIONING SOLUTION
Generic name Accessories, soft lens products
Applicant Polymer Technology Corp.
Product code LPN
Received date Oct 26, 1987
Decision date Dec 1, 1987

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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