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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Decision
Date
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radiesse injectable implant MERZ NORTH AMERICA, INC P050037S070 06/02/2016
essure system BAYER PHARMA AG P020014S044 05/12/2016
iperia 7 hf-t (dr-1) & (df-4); inventra 7 hf-t (df-1) & (df-4) BIOTRONIK, INC. P050023S094 05/02/2016
setrox s 53, safio s 53 BIOTRONIK, INC. P950037S161 05/02/2016
programmer software (1507.u) for the ics 3000/renamic programmers BIOTRONIK, INC. P000009S065 05/02/2016
corox otw 75 bp & 85 bp; corox otw-l 75 bp & 85 bp; corox otw-s 75 bp & 85 bp BIOTRONIK, INC. P070008S070 05/02/2016
precision montage mri spinal cord stimulator system, precision montage spinal cord stimulator system Boston Scientific Corp. P030017S235 04/28/2016
promus premier everolimus-eluting plantinum chromium coronary stent system Boston Scientific Corp. P110010S118 04/19/2016
rebel platinum chromium coronary stent system Boston Scientific Corp. P130030S019 04/19/2016
pathway anti-her-2/neu (4b5)rabbit monoclonal primary antibody VENTANA MEDICAL SYSTEMS, INC. P990081S034 04/13/2016

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