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Device | TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM |
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 | S007 |
Date Received | 09/30/2005 |
Decision Date | 01/04/2007 |
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 MARKET MODEL AR40XEM INTRAOCULAR LENS (IOL) UNDER THE TECNIS TRADE NAME AND FOR THE FOLLOWING LABELING CLAIMS: 1) IMPROVED MESOPIC CONTRAST SENSITIVITY; 2) IMPROVED MESOPIC LOW-CONTRAST ACUITY; AND 3) REDUCED SPHERICAL ABERRATION. |