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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 30 Results
productcode HQL PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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TECNIS Odyssey Toric II Intraocular Lens (IOL) Wit... Johnson & Johnson Surgical Vis P980040 S159 12/22/2023
TECNIS Symfony™ Extended Range Of Vision Intraocul... Johnson & Johnson Surgical Vis P980040 S161 12/22/2023
Clareon PanOptix Pro Trifocal Intraocular Lens (IO... Alcon Laboratories, LLC P190018 S029 12/18/2023
iSert Preloaded IOL System: iSert 250, iSert 251, ... HOYA SURGICAL OPTICS, INC. P080004 S047 10/25/2023
PMMA Single-Piece Posterior Chamber Intraocular Le... ALCON LABORATORIES P840060 S050 10/25/2023
PMMA Single-Piece Anterior Chamber Intraocular Len... ALCON LABORATORIES P880087 S032 10/25/2023
AcrySof® Posterior Chamber Intraocular Lens and De... ALCON LABORATORIES, INC. P930014 S147 10/25/2023
Clareon Aspheric Hydrophobic Acrylic Intraocular L... Alcon Laboratories, LLC P190018 S028 10/24/2023
AcrySof® Posterior Chamber Intraocular Lens and De... ALCON LABORATORIES, INC. P930014 S146 10/24/2023
TECNIS Simplicity Delivery System, SmartLOAD Deliv... Johnson & Johnson Surgical Vis P980040 S163 10/19/2023
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