Visian ICL (Implantable Collamer Lens)
FDA premarket approval P030016/S036 · decided 2019-04-15
Approval details
- PMA number
- P030016
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Visian ICL (Implantable Collamer Lens)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2018-11-02
- Decision date
- 2019-04-15
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval for modification to the labeling for the Visian® Implantable Collamer® Lens, Models MICL and TMICL to reflect the findings of the Adverse Event Post-approval Study for the Visian® MICL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |