• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameNDS LENS MAINTENANCE SYSTEM
Classification Nameaccessories, soft lens products
Generic Namelens cleaner
Regulation Number886.5928
ApplicantCIBA VISION CORPORATION
PMA NumberP900029
Supplement NumberS001
Date Received06/02/1995
Decision Date08/01/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to enhance the instructions to better communicate the proper lens storage timeframes when using the quick care system.
-
-