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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode NWX PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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PMA
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WOLVERINE CORONARY CUTTING BALLOON Boston Scientific Corp. P950020 S078 12/12/2016
Wolverine Coronary Cutting Balloon (Monorail) Boston Scientific Corp. P950020 S076 12/01/2016
WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) A... Boston Scientific Corp. P950020 S077 12/01/2016
WOLVERINE CORONARY CUTTING BALLOON MONORAIL, OVER-... Boston Scientific Corp. P950020 S075 09/27/2016
ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER SPECTRANETICS CORP. P050018 S022 09/06/2016
WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVE... Boston Scientific Corp. P950020 S072 08/18/2016
FLEXTOME CUTTING BALLOON MICROSURGICAL DILITATION ... Boston Scientific Corp. P950020 S073 06/09/2016
ANGIOSCULPT SCORING BALLOON CATHETER SPECTRANETICS CORP. P050018 S021 04/26/2016
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