FDA PMA Approvals

Unknown Device

Applicant DiaSorin, Inc.

PMA Number P990044

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

Applicant DiaSorin, Inc.

PMA Number P990043

Class 2

Unknown Device

Applicant DiaSorin, Inc.

PMA Number P990045

Unknown Device

Applicant DiaSorin, Inc.

PMA Number P990041

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

Applicant DiaSorin, Inc.

PMA Number P990038

Class 2

Somatic gene mutation detection system

Applicant bioMerieux, Inc.

PMA Number P120014

Class 3

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Abbott Laboratories, Inc.

PMA Number P050042

Class 2

Prosthesis, metatarsophalangeal joint cartilage replacement implant

Applicant Cartiva, Inc.

PMA Number P150017

Class 3

Ophthalmic Sealant

Applicant Ocular Therapeutix, Inc.

PMA Number P130004

Class 3

STENT, CORONARY

Applicant Celonova Biosciences, Inc.

PMA Number P160014

Class 3

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant Guidant Corp.

PMA Number P050046

Class 3

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P140032

Class 3