PMA P080004S038
- Device
- iSert Preloaded IOL System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S038
- Product code
- HQL
- Decision date
- 2021-01-08
- Generic name
- intraocular lens
- Approval order statement
- ISert intraocular lens models 230 and 231 to be manufactured on production line 5.
Current openFDA PMA Record#
- Device
- iSert Preloaded IOL System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S038
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-01-08
- Decision code
- OK30
- Date received
- 2020-12-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ISert intraocular lens models 230 and 231 to be manufactured on production line 5.