PMA P980023S005

Device: TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S005
Product code: DTA
Decision date: 2001-10-24
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).

Current openFDA PMA Record#

Device: TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S005
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2001-10-24
Decision code: APPR
Date received: 2001-06-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).