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 | CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVENUE CHINO HILLS, CA 91709 |
PMA Number | P080004 |
Supplement Number | S004 |
Date Received | 01/21/2010 |
Decision Date | 04/04/2012 |
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 FOR CLEAR-OPTIC SPHERIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (IOLS), MODELS PC-60R, PC-60AD AND FC-60AD. |
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