iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
FDA premarket approval P080004/S043 · decided 2021-12-28
Approval details
- PMA number
- P080004
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2021-10-04
- Decision date
- 2021-12-28
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for nine (9) changes to the routine Ethylene Oxide (EO) sterilization process, including:1) The sterilization equipment used in your routine EO sterilization process;2) the implementation of a unified set of EO sterilization process parameters for your US marketed products;3) the lower control limit for EO gas used in your routine EO sterilization process;4) the method for monitoring EO gas concentration;5) the frequency of EO sterilant residuals testing; 6) the Process Challenge Device
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |