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.
 
DeviceBOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14603-0450
PMA NumberP010062
Supplement NumberS005
Date Received12/21/2006
Decision Date02/01/2007
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REMOVING UNIVAL D-49 FROM THE FORMULATION FOR OPRIFOCON A, AND THE REQUESTED LABELING CHANGES.
-
-