- Device
- TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S113
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-08-27
- Decision code
- APPR
- Date received
- 2020-03-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at AMO Puerto Rico Manufacturing Inc., Road 402 North, KM 4.2, Añasco, PR 00610; and, approval for a contract sterilization site located at Edwards Life Sciences Technology SARL, Hwy # 402 North, KM 1.4, Añasco, PR 00610.