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 | ACRYSERT C DELIVERY SYSTEM |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY DR. FORT WORTH, TX 76134 |
PMA Number | P930014 |
Supplement Number | S039 |
Date Received | 02/02/2010 |
Decision Date | 03/29/2010 |
Product Code |
HQL |
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 ACRYSERT C DELIVERY SYSTEM WITH THE ACRYSOF IQ IOL MODEL SN6CWS. |
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