EVO/EVO+ VISIAN® Implantable Collamer® Lenses
FDA premarket approval P030016/S043 · decided 2022-05-04
Approval details
- PMA number
- P030016
- Supplement
- S043
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EVO/EVO+ VISIAN® Implantable Collamer® Lenses
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2022-04-04
- Decision date
- 2022-05-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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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 |