|
Device | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL |
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 | S061 |
Date Received | 03/09/2016 |
Decision Date | 04/01/2016 |
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 Use of a new Multi-piece Auto-dimensional Measurement System to conduct final dimensional inspection of the AcrySof Restor Multi-Piece intraocular lenses. |