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 | PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P880090 |
Supplement Number | S019 |
Date Received | 06/23/2003 |
Decision Date | 07/23/2003 |
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 FREQUENCY OF THE BIOBURDEN TESTING. |
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