STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL)
FDA premarket approval P030016/S022 · decided 2017-03-08
Approval details
- PMA number
- P030016
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2011-12-16
- Decision date
- 2017-03-08
- Days to decision
- 1909 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval for modification of the labeling to reflect the findings of the Follow-up Continuation Post-Approval Study.
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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 |