FDA PMA Approvals

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Roche Molecular Systems, Inc.

PMA Number P190028

Class 3

Temporary non-roller type left heart support blood pump

Applicant Abiomed, Inc.

PMA Number P140003

Class 3

Implant, dermal, for aesthetic use

Applicant Croma-Pharma GmbH

PMA Number P250021

Class 3

Immunohistochemistry Assay, Antibody

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

PMA Number P250031

HEART-VALVE, MECHANICAL

Applicant ABBOTT MEDICAL

PMA Number P810002

Class 3

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

Applicant Merit Medical Systems, Inc.

PMA Number P240023

Class 3

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Bard Peripheral Vascular, Inc.

PMA Number P070014

Class 3

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

Applicant C.R. Bard, Inc.

PMA Number P170042

Class 3

Stent, iliac vein

Applicant Bard Peripheral Vascular, Inc.

PMA Number P180037

Class 3

Transdermal test for Assessment of Glomerular Filtration Rate

Applicant Medibeacon, Inc.

PMA Number P230019

Class 3

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Exact Sciences Corporation

PMA Number P130017

Class 3

Pulmonary valve prosthesis percutaneously delivered

Applicant Medtronic, Inc.

PMA Number P140017

Class f