|
Device | ARTISAN/VERISYSE PHAKIC IOL |
Generic Name | Lens, intraocular, phakic |
Applicant | OPHTEC BV Schweitzerlaan 15 Groningen 9728 |
PMA Number | P030028 |
Supplement Number | S001 |
Date Received | 11/25/2009 |
Decision Date | 11/09/2011 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |