• 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.
 
DevicePAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES
Classification Namelens, contact (orthokeratology)
Generic Namelens, contact (orthokeratology)
Regulation Number886.5916
Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa, AZ 85204
PMA NumberP870024
Supplement NumberS044
Date Received08/31/2004
Decision Date09/24/2004
Product Code
MUW[ Registered Establishments with MUW ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
-
-