PMA P080004S025
- Device
- iSert Preloaded System/ iSert Micro Injector
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S025
- Product code
- HQL
- Decision date
- 2019-11-29
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Approval for design modifications to the slider component of the iSert® injectors.
Current openFDA PMA Record#
- Device
- iSert Preloaded System/ iSert Micro Injector
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S025
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-11-29
- Decision code
- APPR
- Date received
- 2019-09-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design modifications to the slider component of the iSert® injectors.