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.
 
DeviceH55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantTHE COOPER COMPANIES
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS005
Date Received10/23/1995
Decision Date05/06/1997
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CAST MOLDING METHOD FOR THE MANUFACTURE OF THE OCUFILCON D 55% HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR AT THE COMPANY'S FACILITY LOCATED AT SANT ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757.
-
-