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 II OptiBlue Extended Range of Vision (ERV) IOLs |
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 | S131 |
Date Received | 02/09/2021 |
Decision Date | 03/08/2021 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Additional image quality manufacturing process step for the TECNIS Symfony Toric II OptiBlue ERV lOLs, Models ZXW50, ZXW225, ZXW300, ZXW375 manufactured at the AMO Groningen B.V. facility. |
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