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.
 
DeviceSENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantBausch & Lomb, Inc.
14853 Deveau Pl.
Minnetonka, MN 55345
PMA NumberP820031
Supplement NumberS014
Date Received10/10/1996
Decision Date03/10/1997
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REDUCING THE FILL VOLUME FOR RENU(R) LENS REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE.
-
-