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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
PMA NumberP060011
Supplement NumberS005
Date Received02/02/2015
Decision Date05/01/2015
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications of the c-flex aspheric iol model 970c: 1) increase of overall diameter from 12. 00 mm to 12. 50 mm; 2) increase of optic size from 5. 75 mm to 6. 00 mm; and 3) an extension of the high powered dioptric range from +30. 0d to +34. 0d. The device, as modified, will be marketed under the trade name 600c aspheric intraocular lens and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsificationthe lens is intended to be placed in the capsular bag.