|
Device | STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL) |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S018 |
Date Received | 10/14/2010 |
Decision Date | 04/08/2011 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING MODIFICATION TO REFLECT RESULTS FROM AN AXIAL LENGTH POST-APPROVAL STUDY PROTOCOL. |