PMA P080004S024
- Device
- iSert Intraocular Lenses (IOLs)
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S024
- Product code
- HQL
- Decision date
- 2019-08-21
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Modifications to the 1-piece IOL haptic inspection method and acceptance criteria.
Current openFDA PMA Record#
- Device
- iSert Intraocular Lenses (IOLs)
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S024
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-08-21
- Decision code
- OK30
- Date received
- 2019-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the 1-piece IOL haptic inspection method and acceptance criteria.