|
Device | VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S029 |
Date Received | 11/12/2015 |
Decision Date | 12/10/2015 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TO ADD THE GETINGE AUTOCLAVE AS AN ALTERNATE STERILIZER FOR THE VISIAN LENS. |