PMA P980023S003

Device: PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S003
Product code: DTA
Decision date: 2000-05-01
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs.

Current openFDA PMA Record#

Device: PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S003
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2000-05-01
Decision code: APPR
Date received: 1999-11-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs.