- Device
- SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Staar Surgical Co.
- PMA number
- P880091
- Supplement
- S023
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2007-12-04
- Decision code
- APPR
- Date received
- 2007-11-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE APPROVED POLYCARBONATE PACKAGING MATERIAL THAT IS IN DIRECT CONTACT WITH THE LENS DURING STEAM STERILIZATION AND THROUGHOUT THE SHELF-LIFE OF THE LENS.