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 NameBIOFINITY (CONFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP080011
Supplement NumberS018
Date Received09/17/2012
Decision Date11/01/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at coopervision caribbean corporation in juana diaz, puerto rico.
-
-