Aprobaciones FDA PMA

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Solicitante Roche Molecular Systems, Inc.

Número PMA P190028

Clase 3

Temporary non-roller type left heart support blood pump

Solicitante Abiomed, Inc.

Número PMA P140003

Clase 3

Implant, dermal, for aesthetic use

Solicitante Croma-Pharma GmbH

Número PMA P250021

Clase 3

Immunohistochemistry Assay, Antibody

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

Número PMA P250031

VALVULA CARDIACA, MECÁNICA

Solicitante ABBOTT MEDICAL

Número PMA P810002

Clase 3

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

Solicitante Merit Medical Systems, Inc.

Número PMA P240023

Clase 3

STENT, SUPERFICIAL FEMORAL ARTERY

Solicitante Bard Peripheral Vascular, Inc.

Número PMA P070014

Clase 3

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

Solicitante C.R. Bard, Inc.

Número PMA P170042

Clase 3

Stent, iliac vein

Solicitante Bard Peripheral Vascular, Inc.

Número PMA P180037

Clase 3

Transdermal test for Assessment of Glomerular Filtration Rate

Solicitante Medibeacon, Inc.

Número PMA P230019

Clase 3

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Solicitante Exact Sciences Corporation

Número PMA P130017

Clase 3

Pulmonary valve prosthesis percutaneously delivered

Solicitante Medtronic, Inc.

Número PMA P140017

Clase f