- Device
- TECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S122
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-09-23
- Decision code
- OK30
- Date received
- 2020-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a raw material supplier for the polymer resin used to mold the pushrod component in the TECNIS iTEC Preloaded Delivery System and in the TECNIS Simplicity Delivery System.