|
Device | Artisan Myopia Intraocular Lens |
Generic Name | Lens, intraocular, phakic |
Applicant | OPHTEC BV Schweitzerlaan 15 Groningen 9728 |
PMA Number | P030028 |
Supplement Number | S008 |
Date Received | 02/06/2019 |
Decision Date | 05/14/2019 |
Product Code |
MTA |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor labeling changes for the Physician’s Labeling and Patient Brochure. |