Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMINI(R) THETA MODEL 415A CARDIAC PACER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C® Cervical Disc Prosthesis (two-level use)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMINI(R) THETA MODEL 415A CARDIAC PACER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SEQUICOR THETA MODELS 233D & 233E

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SLS SPECTRANETICS LASER SHEATHS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS HYBRID L24 IMPLANT SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM