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 | CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S024 |
Date Received | 07/14/2011 |
Decision Date | 09/08/2011 |
Product Code |
NAA |
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 TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO. |
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