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 SINGLE-PIECE INTRAOCULAR LENSES (IOL) |
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 | S028 |
Date Received | 09/23/2008 |
Decision Date | 10/15/2008 |
Product Code |
HQL |
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 MOVING OF THE IOL FINAL PACKAGING AND SECONDARY LABELING OPERATIONS, WITH THREE (3) SUPPORT FUNCTIONS, INTO THE RECENTLY CONSTRUCTED NEW FACILITY ON THE SAME PROPERTY. |
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