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.
 
DeviceLOTRAFILCON A SOFT CONTACT LENSES
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS037
Date Received03/03/2015
Decision Date04/02/2015
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE LENS WATER CONTENT MEASUREMENT PROCEDURE AT ALCONS BATAM, INDONESIA MANUFACTURING SITE.
-
-