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 ITEC PRELOADED DELIVERY SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS041
Date Received09/04/2012
Decision Date08/21/2013
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
-
-