|
Device | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P060022 |
Supplement Number | S010 |
Date Received | 02/16/2011 |
Decision Date | 10/21/2011 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REMOVAL OF VERBIAGE PERTAINING TO THE CLINICAL ASSESSMENT OF THE ADDITION OF THE ASPHERIC SURFACE. |