PMA P080004S039
- Device
- iSert Preloaded IOL System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S039
- Product code
- HQL
- Decision date
- 2021-01-13
- Generic name
- intraocular lens
- Approval order statement
- Changes to the mold tool used to produce the PSC-60 injection cartridge tip for the 3-piece IOL models.
Current openFDA PMA Record#
- Device
- iSert Preloaded IOL System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S039
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-01-13
- Decision code
- OK30
- Date received
- 2020-12-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the mold tool used to produce the PSC-60 injection cartridge tip for the 3-piece IOL models.