| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT. |
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| Applicant | ABBOTT MEDICAL OPTICS INC
1700 E. St. Andrew Place
Santa Ana, CA 92705 |
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| PMA Number | P960034 |
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| Date Received | 10/01/1996 |
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| Decision Date | 08/12/1998 |
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Withdrawal Date
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10/01/2009 |
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| Docket Number | 98M-0725 |
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| Notice Date | 10/27/1998 |
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| Advisory Committee |
Neurology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval for lens models with the heparin surface modification applied to all your single-piece PMMA lenses approved in P810055. These models will be specified with a "C" following the number designation for the corresponding non-HSM PMMA model. The lenses will be marketed under the trade name CeeOn(TM) HSM PMMA IOLs. This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction (ECCE) or phacoemulsification. They are intended to be placed in the capsular bag. |
| Supplements: |
S001 S002 |
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