Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ACRYSOF RESTOR POSTERIOR CHAMBER 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 | S044 |
Date Received | 12/20/2012 |
Decision Date | 01/17/2013 |
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 | No |
Approval Order Statement NEW CURING OVEN. |
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