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.
 
DeviceFLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
Generic NameLens, contact (orthokeratology)
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP870024
Supplement NumberS045
Date Received12/15/2004
Decision Date01/07/2005
Product Codes MUW MWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
-
-