- Device
- TECNIS Simplicity Delivery System
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S134
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-05-04
- Decision code
- OK30
- Date received
- 2021-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two raw material suppliers for nut and pushrod components of TECNIS Simplicity Delivery System in the AMO Groningen manufacturing facility.