Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | AAREN SCIENTIFIC 4290 EAST BRICKELL ST, BLDG A ONTARIO, CA 91761 |
PMA Number | P970034 |
Supplement Number | S006 |
Date Received | 04/19/2000 |
Decision Date | 08/31/2000 |
Withdrawal Date
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08/20/2014 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
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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