PMA P080004S037
- Device
- iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S037
- Product code
- HQL
- Decision date
- 2020-10-13
- Generic name
- intraocular lens
- Approval order statement
- Manufacturing process change to the buttons used for Hoya's AF-1 family of intraocular lenses.
Current openFDA PMA Record#
- Device
- iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S037
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-10-13
- Decision code
- OK30
- Date received
- 2020-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change to the buttons used for Hoya's AF-1 family of intraocular lenses.