PMA supplement

P880079 S011: CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

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

Key facts

Original PMA P880079
Supplement number S011
Supplement type Normal 180 Day Track
Reason for the supplement Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE
Generic name Accessories, soft lens products
Applicant Ciba Vision Corporation
Product code LPN
Received date Jun 4, 1991
Decision date Dec 3, 1991

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