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Device | ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES |
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 | S052 |
Date Received | 12/19/2013 |
Decision Date | 01/13/2014 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement REDUCE FREQUENCY OF A MANUFACTURING INSPECTION FROM A 100% INSPECTION RATE TO A SAMPLE-BASED INSPECTION PLAN FOR DEVICES WITHIN A LOT. |