PMA P080004S041
- Device
- PreVue Pre-loaded System, IPURE Pre-loaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S041
- Product code
- HQL
- Decision date
- 2021-06-10
- Generic name
- intraocular lens
- Approval order statement
- Qualify a new polymer resin used in the HOYA OEM sterile pouches.
Current openFDA PMA Record#
- Device
- PreVue Pre-loaded System, IPURE Pre-loaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S041
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-06-10
- Decision code
- OK30
- Date received
- 2021-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify a new polymer resin used in the HOYA OEM sterile pouches.