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. |
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Device | FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY |
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 | S004 |
Date Received | 04/15/2003 |
Decision Date | 03/01/2004 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO REVISE THE PACKAGE INSERT WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION. THE LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
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