| 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 | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES |
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| Generic Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | AAREN SCIENTIFIC
4290 EAST BRICKELL ST, BLDG A
ONTARIO, CA 91761 |
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| PMA Number | P970034 |
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| Date Received | 07/21/1997 |
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| Decision Date | 09/25/1998 |
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|
Withdrawal Date
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08/20/2014 |
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| Product Code |
HQL |
| Docket Number | 98M-0855 |
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| Notice Date | 10/27/1998 |
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| Advisory Committee |
Ophthalmic |
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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
Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments. |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 |
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