FDA PMA Approvals

Unknown Device

Applicant Abbott Molecular

PMA Number P030052

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Applicant Abbott Molecular, Inc.

PMA Number P110012

Class 3

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

Applicant Abbott Molecular, Inc.

PMA Number P150041

Class 3

Vagus nerve stimulator for rheumatoid arthritis

Applicant SetPoint Medical

PMA Number P240039

Class 3

Daily wear soft contact lens to reduce the progression of myopia

Applicant CooperVision, Inc.

PMA Number P180035

Class 3

replacement Heart-valve

Applicant Medtronic, Inc.

PMA Number P980043

Class 3

heart-valve, non-allograft tissue

Applicant Medtronic, Inc.

PMA Number P970031

Class 3

Device, thermal ablation, endometrial

Applicant Axora Medical, Inc.

PMA Number P140013

Class 3

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Abbott Laboratories

PMA Number P980007

Class 3

Device, incontinence, mechanical/hydraulic

Applicant Uromedica, Inc.

PMA Number P130018

Class 3

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant Medtronic, Inc.

PMA Number P060039

Class 3

Lens, contact, orthokeratology, overnight

Applicant Contamac, Ltd.

PMA Number P240045

Class 3