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.
 
DeviceSUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS012
Date Received11/09/1989
Decision Date02/28/1990
Withdrawal Date 05/01/2014
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
-
-