CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

FDA premarket approval P910023/S047 · decided 2000-10-27

Approval details

PMA number

P910023

Supplement

S047

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2000-06-14

Decision date

2000-10-27

Days to decision

135 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE PHOTON(TM) DR ICD SYSTEM PROGRAMMER SOFTWARE, MODEL AC-IP IS-1 RECEPTABLE PLUG, AND MODEL 442-2 TORQUE DRIVER/TORQUE WRENCH. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY COMPROMISING VENTRICULAR TACHYARRHYTHMIAS. THESE PATIENTS MAY HAVE EXPERIENCED A CARDIAC ARREST NOT ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION OR HAVE VENTRICULAR TACHYARRHYTHMIAS. IN ADDITION, THE PULSE GENERATOR CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY

510(k) clearances by this applicant