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 | AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P060022 |
Supplement Number | S016 |
Date Received | 04/15/2013 |
Decision Date | 07/01/2013 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO INCLUDE THE ADDITION OF A NEW INTRAOCULAR LENS (IOL) INSERTER, INJ100, IN THE DIRECTIONS FOR USE. |
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