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 | LI61AO LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910061 |
Supplement Number | S015 |
Date Received | 08/30/2006 |
Decision Date | 12/06/2006 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES. |
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