|
Device | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVENUE CHINO HILLS, CA 91709 |
PMA Number | P080004 |
Date Received | 01/31/2008 |
Decision Date | 09/26/2008 |
Product Code |
HQL |
Docket Number | 08M-0536 |
Notice Date | 10/07/2008 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00625313
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S045 S046 S047 |