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.
 
DeviceJSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantEuclid Vision Corporation
45472 Holiday Dr.
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS001
Date Received08/29/2005
Decision Date10/14/2005
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A PROTOCOL OF ACCEPTABLE PROCEDURES TO ALLOW ONE OR MORE INDEPENDENT FINISHING LABORATORIES TO MANUFACTURE AND DISTRIBUTE FINISHED RGP CONTACT LENSES FOR OVERNIGHT ORTHOKERATOLOGY MADE FROM LENS BLANKS.
-
-