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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 109 Results
productcode NIK 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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ACUITY SPIRAL LEAD, ACUITY X4 LEAD Boston Scientific Corp. P010012 S425 07/25/2016
ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-el... Boston Scientific Corp. P010012 S416 06/09/2016
ACUITY X4 Drug Collar Component Dwell Time Boston Scientific Corp. P010012 S430 09/01/2016
ACUITY X4 lead family shelf life Boston Scientific Corp. P010012 S437 12/21/2016
ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677... Boston Scientific Corp. P010012 S440 12/19/2016
ACUITY X4 STRAIGHT, ACUITY X4 SPIRAL S, ACUITY X4 ... Boston Scientific Corp. P010012 S423 08/23/2016
ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, IN... Boston Scientific Corp. P010012 S428 08/02/2016
ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES Abbott Medical P030035 S144 01/04/2016
Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S559 09/15/2016
Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S562 10/24/2016
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