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.
 
Device600C ASPHERIC INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRayner Intraocular Lenses , Ltd.
1-2 Sackville Trading Estate,
Sackville Rd.
Hove, E. Sussex BN3 7AN
PMA NumberP060011
Supplement NumberS005
Date Received02/02/2015
Decision Date05/01/2015
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATIONTHE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
-
-