PMA P080004S029
- Device
- iSert Preloaded IOL Models, iSymm, Clarisert IOL Models
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S029
- Product code
- HQL
- Decision date
- 2019-12-30
- Generic name
- intraocular lens
- Approval order statement
- Addition of a second supplier of ethylene oxide gas for use in the ethylene oxide sterilization process.
Current openFDA PMA Record#
- Device
- iSert Preloaded IOL Models, iSymm, Clarisert IOL Models
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S029
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-12-30
- Decision code
- OK30
- Date received
- 2019-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second supplier of ethylene oxide gas for use in the ethylene oxide sterilization process.