PMA P030028S010

Device: Artisan Myopia
Applicant: Ophtec BV
PMA number: P030028
Supplement: S010
Product code: MTA
Decision date: 2024-11-15
Classification: Ophthalmic
Generic name: Lens, intraocular, phakic
Approval order statement: Approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Artisan Myopia Intraocular Lens.

Current openFDA PMA Record#

Device: Artisan Myopia
Applicant: Ophtec BV
PMA number: P030028
Supplement: S010
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2024-11-15
Decision code: APPR
Date received: 2022-03-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Artisan Myopia Intraocular Lens.