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U.S. Department of Health and Human Services

Premarket Approval - PMA

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PMA
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freezor cardiac cryoablation system Medtronic CryoCath LP P020045S049 08/07/2013
cryoconsole Medtronic CryoCath LP P020045S064 05/11/2015
procol vascular bioprosthesis LEMAITRE VASCULAR INC P020049S003 09/29/2014
wavelight ex500 excimer laser system Alcon Laboratories, Inc. P020050S015 04/10/2014
wave light ex500 laser system Alcon Laboratories, Inc. P020050S017 12/17/2014
wavelight ex500 laser system Alcon Laboratories, Inc. P020050S018 01/20/2015
pathway anti-c-kit (9.7) rabbitt monoclonal primary antobody VENTANA MEDICAL SYSTEMS, INC. P020055S010 06/13/2014
natrelle silicone gel-filled breast implants Allergan P020056S029 01/16/2015
trulign toric web-based toric calculator Bausch & Lomb, Inc. P030002S033 04/09/2015
trulign toric web based toric calculator Bausch & Lomb, Inc. P030002S036 02/17/2016

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