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 NameVISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS042
Date Received07/30/2009
Decision Date02/19/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the stability protocol utilized to establish shelf-life.
-
-