FDA-PMA-Zulassungen

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Antragsteller Allurion Technologies, Inc.

PMA-Nummer P250023

Klasse 3

Stimulator, spinal-cord, totally implanted for pain relief

Antragsteller Boston Scientific Corp

PMA-Nummer P030017

Klasse 3

Stimulator, electrical, implanted, for parkinsonian symptoms

Antragsteller Boston Scientific Corp

PMA-Nummer P150031

Klasse 3

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

Antragsteller Siemens Healthcare Diagnostics, Inc.

PMA-Nummer P930027

Klasse 3

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

Antragsteller Siemens Medical Solutions Diagnostics Limited

PMA-Nummer P060005

Klasse 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Antragsteller Siemens Healthcare Diagnostics, Inc.

PMA-Nummer P010007

Klasse 3

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

Antragsteller ABBOTT MEDICAL

PMA-Nummer P220013

Klasse 3

Prosthesis, intervertebral disc

Antragsteller Spineart USA, Inc.

PMA-Nummer P250042

Klasse 3

Unknown Device

Antragsteller Agilent Technologies, Inc.

PMA-Nummer P150025

Immunohistochemistry assay, antibody, programmed death-ligand 1

Antragsteller Agilent Technologies, Inc.

PMA-Nummer P150013

Klasse 3

SYSTEM, TEST, HER-2/NEU, IHC

Antragsteller Agilent Technologies Singapore (International) Pte , Ltd.

PMA-Nummer P980018

Klasse 3

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

Antragsteller Agilent Technologies, Inc.

PMA-Nummer P230016

Klasse 3