|
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 | S028 |
Date Received | 10/19/2015 |
Decision Date | 11/17/2015 |
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 THE REPLACEMENT OF AN INSTRUMENT TO MEASURE DIOPTRIC POWER AND IMAGE QUALITY (MTF) AT FINAL PRODUCT INSPECTION. |