FDA PMA Approvals

Somatic gene mutation detection system

Applicant Entrogen, Inc.

PMA Number P220005

Class 3

Device, hemostasis, vascular

Applicant Terumo Medical Corporation

PMA Number P210017

Class 3

Unknown Device

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010053

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Trireme Medical, LLC

PMA Number P210039

Class 3

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant Cardiofocus, Inc.

PMA Number P150026

Class 3

Acid, hyaluronic, intraarticular

Applicant Anika Therapeutics, Inc.

PMA Number P090031

Class 3

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

Applicant Exact Sciences Corporation

PMA Number P210040

Class 3

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P210002

Class 3

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P190026

Class 3

AID, SURGICAL, VISCOELASTIC

Applicant Bausch & Lomb, Inc.

PMA Number P810025

Class 3

Lens, contact (rigid gas permeable), extended wear

Applicant Menicon Co, Ltd.

PMA Number P990018

Class 3

STENT, CORONARY

Applicant Abbott Vascular

PMA Number P020047

Class 3