• 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
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantBAUSCH & LOMB, INC.
PMA NumberP860023
Supplement NumberS010
Date Received04/03/1996
Decision Date09/27/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying the current eye care practitioner trial lens disinfection and storage instructions to extend the maximum recommended storage time from the currently approved 7 days to 30 days in bausch & lomb re nu multi-purpose solution. All other aspects of the labeling remain unchanged from those previously approved.