FDA PMA Approvals

Unknown Device

Applicant Bausch & Lomb, Inc.

PMA Number P960022

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant Spectranetics Corp.

PMA Number P050018

Class 3

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories, Inc.

PMA Number P050051

Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories

PMA Number P110029

Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories

PMA Number P060035

Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories

PMA Number P080023

Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Abbott Laboratories

PMA Number P210003

Class 2

Stimulator, bone growth, non-invasive

Applicant Orthofix US, LLC

PMA Number P210035

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P970012

Class 3

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P820003

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P990001

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P930022

Class 3