|
Device | 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 | S025 |
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. |