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 | SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910061 |
Supplement Number | S019 |
Date Received | 11/02/2009 |
Decision Date | 12/02/2009 |
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 CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA. |
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