PMA P980040S137

Device: TECNIS Simplicity Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S137
Product code: HQL
Decision date: 2021-06-29
Generic name: intraocular lens
Approval order statement: Addition of an alternate sterilization chamber for sterilization of the subject intraocular lenses preloaded in the TECNIS Simplicity Delivery System.

Current openFDA PMA Record#

Device: TECNIS Simplicity Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S137
Product code: HQL
Generic name: intraocular lens
Decision date: 2021-06-29
Decision code: OK30
Date received: 2021-06-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate sterilization chamber for sterilization of the subject intraocular lenses preloaded in the TECNIS Simplicity Delivery System.