|
Device | ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL) |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P960028 |
Supplement Number | S009 |
Date Received | 06/02/2003 |
Decision Date | 08/29/2003 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENDING THE POWER RANGE OF THE ARRAY 2 MODEL SA44 MULTIFOCAL IOL UP TO 35 DIOPTERS. |