PMA P980023S009

Device: KAINOX RV-S/ KAINOX VCS ICD LEADS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S009
Product code: DTA
Decision date: 2002-11-25
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS. TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.

Current openFDA PMA Record#

Device: KAINOX RV-S/ KAINOX VCS ICD LEADS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S009
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2002-11-25
Decision code: APPR
Date received: 2002-06-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS. TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.