FDA PMA 승인

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

신청자 Allurion Technologies, Inc.

PMA 번호 P250023

등급 3

Stimulator, spinal-cord, totally implanted for pain relief

신청자 Boston Scientific Corp

PMA 번호 P030017

등급 3

Stimulator, electrical, implanted, for parkinsonian symptoms

신청자 Boston Scientific Corp

PMA 번호 P150031

등급 3

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

신청자 Siemens Healthcare Diagnostics, Inc.

PMA 번호 P930027

등급 3

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

신청자 Siemens Medical Solutions Diagnostics Limited

PMA 번호 P060005

등급 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

신청자 Siemens Healthcare Diagnostics, Inc.

PMA 번호 P010007

등급 3

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

신청자 ABBOTT MEDICAL

PMA 번호 P220013

등급 3

Prosthesis, intervertebral disc

신청자 Spineart USA, Inc.

PMA 번호 P250042

등급 3

Unknown Device

신청자 Agilent Technologies, Inc.

PMA 번호 P150025

Immunohistochemistry assay, antibody, programmed death-ligand 1

신청자 Agilent Technologies, Inc.

PMA 번호 P150013

등급 3

SYSTEM, TEST, HER-2/NEU, IHC

신청자 Agilent Technologies Singapore (International) Pte , Ltd.

PMA 번호 P980018

등급 3

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

신청자 Agilent Technologies, Inc.

PMA 번호 P230016

등급 3