PMA P080004S027
- Device
- iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S027
- Product code
- HQL
- Decision date
- 2019-12-04
- Generic name
- intraocular lens
- Approval order statement
- Alternate supplier for applying ceramic coating to stainless steel jigs.
Current openFDA PMA Record#
- Device
- iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S027
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-12-04
- Decision code
- OK30
- Date received
- 2019-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for applying ceramic coating to stainless steel jigs.