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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 57 Results
productcode HQL PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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iSert Preloaded IOL Models, iSymm, Clarisert IOL M... HOYA SURGICAL OPTICS, INC. P080004 S029 12/30/2019
AcrySof Intraocular Lenses ALCON LABORATORIES, INC. P930014 S120 12/30/2019
iSymm, iSpheric IOL HOYA SURGICAL OPTICS, INC. P080004 S026 12/04/2019
iSert Preloaded System, iSpheric, iSymm IOL Models... HOYA SURGICAL OPTICS, INC. P080004 S027 12/04/2019
iSert Preloaded System/ iSert Micro Injector HOYA SURGICAL OPTICS, INC. P080004 S025 11/29/2019
SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery ... Johnson & Johnson Surgical Vis P980040 S110 11/22/2019
HOYA iSert 250/251 and Clarisert Pre-Loaded IOL In... HOYA SURGICAL OPTICS, INC. P080004 S023 10/25/2019
TECNIS Toric II 1-Piece Intraocular Lenses and TEC... Johnson & Johnson Surgical Vis P980040 S103 10/23/2019
Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1... Johnson & Johnson Surgical Vis P980040 S108 10/15/2019
Tecnis 3-Piece Acrylic Monofocal Johnson & Johnson Surgical Vis P990080 S051 10/15/2019
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