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 | SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S015 |
Date Received | 05/18/2007 |
Decision Date | 10/30/2007 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TWO NEW MODELS OF SENSAR SOFT ACRYLIC UV LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) AND THE CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE NEW MODELS ARE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL AAB00) AND TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL ZCB00). THE TWO MODELS DIFFER FROM THE PARENT MODELS AS FOLLOWS: SINGLE PIECE DESIGN, THE ADDITION OF A SURFACE TREATMENT TO THE ACRYLIC MATERIAL, AND SLIGHT REDUCTION IN THE CENTER THICKNESS WITH ZERO ANGULATION. |
|
|