FDA PMA Approvals

Hepatitis Viral B DNA Detection

Applicant Roche Molecular Systems, Inc.

PMA Number P050028

Class 2

Unknown Device

Applicant Myriad Genetic Laboratories

PMA Number P140020

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

Applicant ARUP Laboratories

PMA Number P190033

Class 3

Unknown Device

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P880081

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Endologix, LLC

PMA Number P040002

Class 3

Somatic gene mutation detection system

Applicant Invivoscribe Technologies, Inc.

PMA Number P160040

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Pillar Biosciences

PMA Number P200011

Class 3

Intravascular radiation delivery system

Applicant Best Vascular, Inc.

PMA Number P000018

Class 3

Stimulator, invasive bone growth

Applicant Ahp Eos Buyer, Inc.

PMA Number P850035

Class 3

Cytomegalovirus (cmv) dna quantitative assay

Applicant Abbott Molecular, Inc.

PMA Number P210022

Class 2

Processor, cervical cytology slide, automated

Applicant Bd Diagnostic Systems

PMA Number P970018

Class 3

Pulmonary stent

Applicant Cordis US Corp

PMA Number P220004

Class 3