FDA PMA Approvals

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

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

Applicant bioMerieux, Inc.

PMA Number P040008

Class 3

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P000009

Class 3

Lens, contact, orthokeratology, overnight

Applicant Euclid Vision Corporation

PMA Number P040029

Class 3

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P090016

Class 3

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Medtimo, Inc.

PMA Number P000008

Class 3

Acid, hyaluronic, intraarticular

Applicant Ibsa Institut Biochimique SA

PMA Number P110005

Class 3

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Boston Scientific Corporation

PMA Number P140008

Class 3

AID, SURGICAL, VISCOELASTIC

Applicant Alcon Research, Ltd.

PMA Number P890047

Class 3