FDA PMA Approvals

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Allurion Technologies, Inc.

PMA Number P250023

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Boston Scientific Corp

PMA Number P030017

Class 3

Stimulator, electrical, implanted, for parkinsonian symptoms

Applicant Boston Scientific Corp

PMA Number P150031

Class 3

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

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P930027

Class 3

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

Applicant Siemens Medical Solutions Diagnostics Limited

PMA Number P060005

Class 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P010007

Class 3

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

Applicant ABBOTT MEDICAL

PMA Number P220013

Class 3

Prosthesis, intervertebral disc

Applicant Spineart USA, Inc.

PMA Number P250042

Class 3

Unknown Device

Applicant Agilent Technologies, Inc.

PMA Number P150025

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Agilent Technologies, Inc.

PMA Number P150013

Class 3

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Agilent Technologies Singapore (International) Pte , Ltd.

PMA Number P980018

Class 3

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

Applicant Agilent Technologies, Inc.

PMA Number P230016

Class 3