VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
FDA premarket approval P030016/S030 · decided 2017-01-25
Approval details
- PMA number
- P030016
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2017-01-05
- Decision date
- 2017-01-25
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Manufacture of an in-process aid at the STAAR Monrovia, CA manufacturing site as an alternative to the current supplier.
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 |