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. |
|
Device | SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990080 |
Supplement Number | S002 |
Date Received | 09/13/2002 |
Decision Date | 09/24/2002 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW TRADE NAME FOR THE MODEL Z9000 FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS, AND OTHER LENS MODELS WHICH INCORPORATE THE MODIFIED PROLATE ANTERIOR OPTIC SURFACE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNIS, WITH Z-SHARP OPTIC TECHNOLOGY 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 PHACOEMULSIFI-CATION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
|
|