PMA P980040S105

Device: TECNIS iTec Preloaded Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S105
Product code: HQL
Decision date: 2019-08-07
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Alternate testing facility to evaluate bioburden for the TECNIS® 1-Piece IOL with TECNIS iTec Preloaded Delivery System Model PCB00 and TECNIS® iTec Preloaded Delivery System, Model PMB00.

Current openFDA PMA Record#

Device: TECNIS iTec Preloaded Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S105
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-08-07
Decision code: OK30
Date received: 2019-07-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate testing facility to evaluate bioburden for the TECNIS® 1-Piece IOL with TECNIS iTec Preloaded Delivery System Model PCB00 and TECNIS® iTec Preloaded Delivery System, Model PMB00.