PMA P080004S032
- Device
- iSert Preloaded IOL System, Intraocular Lens - Clarisert
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S032
- Product code
- HQL
- Decision date
- 2020-03-12
- Generic name
- intraocular lens
- Approval order statement
- Change in the tip coating process.
Current openFDA PMA Record#
- Device
- iSert Preloaded IOL System, Intraocular Lens - Clarisert
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S032
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-03-12
- Decision code
- OK30
- Date received
- 2020-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the tip coating process.