PMA P980040S106

Device: TECNIS iTEC Preloaded Delivery System
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S106
Product code: HQL
Decision date: 2019-09-11
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Addition of an alternate supplier for the nut component used for the TECNIS® 1-Piece Intraocular Lens (IOL) with the TECNIS® iTEC Preloaded Delivery System, Model PCB00 and TECNIS® Multifocal 1-Piece IOL with the 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: S106
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-09-11
Decision code: OK30
Date received: 2019-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate supplier for the nut component used for the TECNIS® 1-Piece Intraocular Lens (IOL) with the TECNIS® iTEC Preloaded Delivery System, Model PCB00 and TECNIS® Multifocal 1-Piece IOL with the TECNIS® iTEC Preloaded Delivery System, Model PMB00.