- Device
- TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S051
- Decision date
- 2014-11-12
- Decision code
- OK30
- Date received
- 2014-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDING AN ALTERNATE MOLDING SUPPLIER FOR THE CARTRIDGE COMPONENT USED IN THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.