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 | ONE PIECE POSTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Irvine, CA 92618 |
PMA Number | P840039 |
Supplement Number | S049 |
Date Received | 12/19/1995 |
Decision Date | 06/05/1996 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO EXTEND THE POWER RANGE FOR YOUR ONE-PIECE POSTERIOR CHAMBER IOLS FORM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D). |
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