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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLOTRAFILCON B SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP010019
Supplement NumberS032
Date Received05/04/2012
Decision Date05/22/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate raw material supplier for betacon macromer used in the formulation of lotrafilcon b soft contact lenses.
-
-