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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
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Decision
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jewel af, gem iii at MEDTRONIC Inc. P980050S101 08/17/2015
diva family includes diamond ii, ruby ii, topaz ii, jade 11, vita dddr, vita ddd and vita vvir MEDTRONIC Inc. P980050S082 06/11/2013
ovatio vr and ovatio dr icds MicroPort CRM USA Inc. P980049S051 12/14/2009
access afp reagents on the access immunoassay systems BECKMAN COULTER, INC. P980041S026 10/17/2013
access afp reagents on the access immunoassay systems BECKMAN COULTER, INC. P980041S018 11/19/2012
amo sensar soft acrylic intraocular lenses (iol) (models ar40e/ar40e/ar40m/ar40mn) & tecnis 1 piece intraocular lens Johnson & Johnson Surgical Vision, Inc. P980040S037 04/23/2012
angiojet rheolytic thrombectomy system Boston Scientific Corp. P980037S044 05/14/2015
adapta, versa, sensia ipg, relia ipg MEDTRONIC Inc. P980035S733 11/18/2022
adapta, versa, sensia, advisa, advisa mri,enpulse, kappa MEDTRONIC Inc. P980035S450 02/22/2016
adapta, versa, sensia, advisa, advisa mri, enpulse, kappa ipgs MEDTRONIC Inc. P980035S446 12/08/2015

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