FDA-PMA-Zulassungen

Hepatitis Viral B DNA Detection

Antragsteller Roche Molecular Systems, Inc.

PMA-Nummer P050028

Klasse 2

Unknown Device

Antragsteller Myriad Genetic Laboratories

PMA-Nummer P140020

Assays zur Detektion vorge spiritueller Antikörper gegen adenovirale Vektoren (AAV)

Antragsteller ARUP Laboratories

PMA-Nummer P190033

Klasse 3

Unknown Device

Antragsteller Johnson & Johnson Surgical Vision, Inc.

PMA-Nummer P880081

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Antragsteller Endologix, LLC

PMA-Nummer P040002

Klasse 3

Somatic gene mutation detection system

Antragsteller Invivoscribe Technologies, Inc.

PMA-Nummer P160040

Klasse 3

Next generation sequencing oncology panel, somatische oder germline Varianten-Detektionssystem

Antragsteller Pillar Biosciences

PMA-Nummer P200011

Klasse 3

Intravascular radiation delivery system

Antragsteller Best Vascular, Inc.

PMA-Nummer P000018

Klasse 3

Stimulator, invasive bone growth

Antragsteller Ahp Eos Buyer, Inc.

PMA-Nummer P850035

Klasse 3

Cytomegalovirus (CMV) DNA quantitative Assay

Antragsteller Abbott Molecular, Inc.

PMA-Nummer P210022

Klasse 2

Processor, cervical cytology slide, automated

Antragsteller Bd Diagnostic Systems

PMA-Nummer P970018

Klasse 3

Pulmonary stent

Antragsteller Cordis US Corp

PMA-Nummer P220004

Klasse 3