|
Device | ARTISAN MYOPIA PHAKIC IOL |
Generic Name | Lens, intraocular, phakic |
Applicant | OPHTEC BV Schweitzerlaan 15 Groningen 9728 |
PMA Number | P030028 |
Supplement Number | S002 |
Date Received | 10/29/2010 |
Decision Date | 11/23/2010 |
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 SHORTENING OF ETHYLENE OXIDE DEGASSING PHASE PROCESS AND THE ADDITION OF AN ADDITIONAL STERILIZATION CONFIGURATION. |
Post-Approval Study | Show Report Schedule and Study Progress |