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Device | enVista® Hydrophobic Acrylic Intraocular Lens (IOL) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910056 |
Supplement Number | S050 |
Date Received | 10/28/2022 |
Decision Date | 02/22/2024 |
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 addition of an automate measurements system and specific programs as an alternative for dimensional inspection of enVista Hydrophobic Acrylic Intraocular Lenses |