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. |
|
Device | ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3 |
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 | S003 |
Date Received | 10/31/2006 |
Decision Date | 01/30/2007 |
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 THE ADDITION OF A PROLATE SURFACE TO THE ANTERIOR OPTIC, CHANGING THE OPTIC SHAPE FACTOR TO BE MORE EQUICONVEX, AND THE USE OF NATURAL MATERIAL. |
|
|