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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.
 
Trade NamePOSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber intraocular lenses
Regulation Number886.3600
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS006
Date Received04/19/2000
Decision Date08/31/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the power range for your lenses to include powers between +3. 5 and -12. 0 diopters (excluding zero diopter) in 0. 5 diopter increments.
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