Aprovações FDA PMA

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Requerente Allurion Technologies, Inc.

Número PMA P250023

Classe 3

Stimulator, spinal-cord, totally implanted for pain relief

Requerente Boston Scientific Corp

Número PMA P030017

Classe 3

Stimulator, electrical, implanted, for parkinsonian symptoms

Requerente Boston Scientific Corp

Número PMA P150031

Classe 3

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Requerente Siemens Healthcare Diagnostics, Inc.

Número PMA P930027

Classe 3

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

Requerente Siemens Medical Solutions Diagnostics Limited

Número PMA P060005

Classe 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Requerente Siemens Healthcare Diagnostics, Inc.

Número PMA P010007

Classe 3

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

Requerente ABBOTT MEDICAL

Número PMA P220013

Classe 3

Prosthesis, intervertebral disc

Requerente Spineart USA, Inc.

Número PMA P250042

Classe 3

Unknown Device

Requerente Agilent Technologies, Inc.

Número PMA P150025

Immunohistochemistry assay, antibody, programmed death-ligand 1

Requerente Agilent Technologies, Inc.

Número PMA P150013

Classe 3

SYSTEM, TEST, HER-2/NEU, IHC

Requerente Agilent Technologies Singapore (International) Pte , Ltd.

Número PMA P980018

Classe 3

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

Requerente Agilent Technologies, Inc.

Número PMA P230016

Classe 3