ISERT MODEL PC-60AD PACKAGING IMPROVEMENT
FDA premarket approval P080004/S012 · decided 2012-07-17
Approval details
- PMA number
- P080004
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISERT MODEL PC-60AD PACKAGING IMPROVEMENT
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2012-05-29
- Decision date
- 2012-07-17
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL FOR A PACKAGING CONFIGURATION CHANGE FOR THE ISERT MODEL PC-60AD INTRAOCULAR LENS (IOL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT MODEL 230 AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
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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 |