FDA-PMA-Zulassungen

KIT, DNA-Detektion, Human Papillomavirus

Antragsteller Roche Molecular Systems, Inc.

PMA-Nummer P190028

Klasse 3

Temporary non-roller type left heart support blood pump

Antragsteller Abiomed, Inc.

PMA-Nummer P140003

Klasse 3

Implantat, dermatologisches, für ästhetische Zwecke

Antragsteller Croma-Pharma GmbH

PMA-Nummer P250021

Klasse 3

Immunohistochemistry Assay, Antibody

Antragsteller Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

PMA-Nummer P250031

HEART-VALVE, MECHANICAL

Antragsteller ABBOTT MEDICAL

PMA-Nummer P810002

Klasse 3

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Antragsteller Merit Medical Systems, Inc.

PMA-Nummer P240023

Klasse 3

STENT, SUPERFICIAL FEMORAL ARTERY

Antragsteller Bard Peripheral Vascular, Inc.

PMA-Nummer P070014

Klasse 3

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Antragsteller C.R. Bard, Inc.

PMA-Nummer P170042

Klasse 3

Stent, iliac vein

Antragsteller Bard Peripheral Vascular, Inc.

PMA-Nummer P180037

Klasse 3

Transdermal test for Assessment of Glomerular Filtration Rate

Antragsteller Medibeacon, Inc.

PMA-Nummer P230019

Klasse 3

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Antragsteller Exact Sciences Corporation

PMA-Nummer P130017

Klasse 3

Pulmonary valve prosthesis percutaneously delivered

Antragsteller Medtronic, Inc.

PMA-Nummer P140017

Klasse f