|
Device | ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S029 |
Date Received | 11/01/2010 |
Decision Date | 06/30/2011 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON LABORATORIES IRELAND LTD. IN CORK, IRELAND. |