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Device | Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL) |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S040 |
Date Received | 12/22/2021 |
Decision Date | 01/19/2022 |
Product Code |
NAA |
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 Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses. |