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Device | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB INCORPORATED 50 Technology Drive Irvine, CA 92618 |
PMA Number | P080021 |
Date Received | 08/07/2008 |
Decision Date | 02/02/2009 |
Product Code |
HQL |
Docket Number | 09M-0049 |
Notice Date | 02/06/2009 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL). MODEL X-60 AND MODEL X-70. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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