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Device | TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL |
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 | S140 |
Date Received | 06/25/2021 |
Decision Date | 12/01/2021 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to lathe cutting and cryotumbling processes and image quality inspection equipment for manufacturing of TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses. |