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.
 
DeviceTECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS023
Date Received03/21/2008
Decision Date05/27/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE LABELING FOR THE TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 AS FOLLOWS: 1) MODIFICATIONS TO THE DEVICE DESCRIPTION SECTION TO INCLUDE AN ADDITIONAL DESCRIPTION OF WAVEFRONT-DESIGNED ASPHERIC OPTIC, SQUARED POSTERIOR OPTIC EDGE, FROSTED OPTIC EDGE, AN OPTICAL IMAGE QUALITY GRAPH FOR THE ASPHERIC OPTIC; 2) MODIFICATIONS TO THE ADVERSE EVENTS SAND THE CLINICAL TRIAL SECTIONS TO REFLECT DATA FROM THE ONE-YEAR CLINICAL STUDY RESULTS; AND 3) OTHER ADMINISTRATIVE CHANGES SUCH AS THE REWORDING OF THE LAST SENTENCE ON PAGE 1, ADDING TRADEMARKS TO THE DETAILED DEVICE DESCRIPTION SECTION AND REVISION THE NUMBERING OF THE FIGURES.
-
-