VISIAN IMPLANTABLE COLLAMER LENSES
FDA premarket approval P030016/S027 · decided 2014-12-22
Approval details
- PMA number
- P030016
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISIAN IMPLANTABLE COLLAMER LENSES
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2014-04-14
- Decision date
- 2014-12-22
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL TO ADD NEW CALCULATOR SOFTWARE TO THE VISIAN IMPLANTABLE COLLAMER LENS (ICL).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| MicroSTAAR Injector System Cartridges (K152357) | STAAR Surgical Company | 2015-10-30 |