|
Device | VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA |
Generic Name | Lens, intraocular, phakic |
Applicant | STAAR Surgical Company 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P030016 |
Supplement Number | S017 |
Date Received | 08/17/2010 |
Decision Date | 09/15/2010 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING STATEMENT AND A MODIFICATION TO A CONTRAINDICATION. |