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.
 
DeviceSILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990080
Supplement NumberS001
Date Received09/05/2001
Decision Date10/16/2001
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW FOLDABLE, ULTRAVIOLET LIGHT-ABSORBING, POSTERIOR CHAMBER INTRAOCULAR LENS MODEL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL Z9000 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
-
-