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 | Trulign® Toric Posterior Chamber Intraocular Lens (IOL) |
Generic Name | Lens, intraocular, accommodative |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S039 |
Date Received | 10/12/2021 |
Decision Date | 04/08/2022 |
Product Codes |
MJP NAA |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT02394379
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revised device labeling to describe results of the New Enrollment Study Post Approval Study (PAS) protocol. |
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