IPure Preloaded IOL System
FDA premarket approval P080004/S030 · decided 2020-04-17
Approval details
- PMA number
- P080004
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IPure Preloaded IOL System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2019-12-16
- Decision date
- 2020-04-17
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for packaging changes for the iSert® Preloaded System Platform Models 250 and 251. This device, as modified, will be marketed under the tradename IPure Preloaded System Platform Models B1PC and B1PY 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 |