• 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 NumberS012
Date Received11/13/1996
Decision Date07/03/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the formulation and corresponding modifications to the labeling. The device, as modified, will be marketed under the trade name bausch & lomb renu multiplus(tm) multi-purpose solution and is indicated for use in the daily cleaning, promotion of daily protein removal, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.