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 Posterior Chamber Intraocular Lenses |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Irvine, CA 92618 |
PMA Number | P840039 |
Supplement Number | S063 |
Date Received | 01/04/2019 |
Decision Date | 02/28/2019 |
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 Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and PMMA intraocular lenses be transferred to a new testing laboratory. |
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