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 | TECNIS Symfony Toric Extended Range of Vision Intraocular Lens |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S099 |
Date Received | 12/28/2018 |
Decision Date | 06/26/2019 |
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 the extension of the cylinder power range of the TECNIS Symfony Toric IOL line to include the cylinder powers 4.50D, 5.25D, and 6.00D. |
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