PMA P980023S007

Device: KENTROX RV LEAD SYSTEMS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S007
Product code: DTA
Decision date: 2002-02-21
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR A NAME CHANGE FOR THE TEROX RV 65 AND TEROX RV 75 LEADS. THE DEVICE WILL NOW BE MARKETED UNDER THE TRADE NAME KENTROX RV 65 (MODEL 332 232) AND KENTROX RV 75 (MODEL 332 231) AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).

Current openFDA PMA Record#

Device: KENTROX RV LEAD SYSTEMS
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S007
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2002-02-21
Decision code: APPR
Date received: 2002-01-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A NAME CHANGE FOR THE TEROX RV 65 AND TEROX RV 75 LEADS. THE DEVICE WILL NOW BE MARKETED UNDER THE TRADE NAME KENTROX RV 65 (MODEL 332 232) AND KENTROX RV 75 (MODEL 332 231) AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).