ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
FDA premarket approval P080004/S001 · decided 2009-08-07
Approval details
- PMA number
- P080004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2009-01-14
- Decision date
- 2009-08-07
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL TO ADD A NEW PACKAGING CONFIGURATION WHEREIN THE HOYA SURGICAL OPTICS INTRAOCULAR LENSES (IOLS) WILL BE PACKAGED IN A DISPOSABLE, PLASTIC INJECTOR.
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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 |