|
Device | ARTISAN-VERISYSE MYOPIA PHAKIC IOL |
Generic Name | Lens, intraocular, phakic |
Applicant | OPHTEC BV Schweitzerlaan 15 Groningen 9728 |
PMA Number | P030028 |
Supplement Number | S003 |
Date Received | 01/05/2012 |
Decision Date | 02/03/2012 |
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 CHANGE IN THE POLY-METHYL METHACRYLATE (PMMA) MATERIAL. |