Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantBausch & Lomb, Inc.
14853 DEVEAU PLACE
MINNETONKA, MN 55345
PMA NumberP860023
Supplement NumberS010
Date Received04/03/1996
Decision Date09/27/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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
-
-