FDA PMA Approvals

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Boston Scientific

PMA Number P960006

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P930035

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P940008

Class 3

intraocular lens

Applicant Bausch & Lomb, Inc.

PMA Number P060022

Class 3

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Applicant Bd Diagnostics

PMA Number P950009

Class 3

DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Applicant Spectranetics (Philips)

PMA Number P960042

Class 3

intraocular lens

Applicant Bausch & Lomb, Inc.

PMA Number P840039

Class 3

intraocular lens

Applicant Bausch & Lomb, Inc.

PMA Number P880090

Class 3

Ventricular (assist) bypass

Applicant Thoratec Laboratories Corp.

PMA Number P870072

Class 3

STENT, ILIAC

Applicant Cordis US Corporation

PMA Number P020036

Class 3

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

Applicant DiaSorin, Inc.

PMA Number P990042

Class 2

Unknown Device

Applicant DiaSorin, Inc.

PMA Number P990044