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 IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS |
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 | S015 |
Date Received | 04/02/2009 |
Decision Date | 05/28/2009 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN EXPANSION OF THE DIOPTRIC RANGE TO INCLUDE 6.0 TO 9.5 DIOPTERS IN ½ DIOPTER INCREMENTS FOR MODELS SN6AD1, MN6AD1 AND SN6AD3. |
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