PMA P980023S006

Device
BELOS VR ICD SYSTEM
Applicant
Biotronik, Inc.
PMA number
P980023
Supplement
S006
Product code
DTA
Decision date
2002-03-11
Classification
Tester, Pacemaker Electrode Function
Generic name
TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement
APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE I-K01.0.A/4, MINOR EMBEDDED SOFTWARE CHANGES, MINOR HARDWARE CHANGES, AND A CORRECTION TO THE "USE BEFORE" DATE.

Current openFDA PMA Record#

Device
BELOS VR ICD SYSTEM
Applicant
Biotronik, Inc.
PMA number
P980023
Supplement
S006
Product code
DTA
Generic name
TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date
2002-03-11
Decision code
APPR
Date received
2002-02-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE I-K01.0.A/4, MINOR EMBEDDED SOFTWARE CHANGES, MINOR HARDWARE CHANGES, AND A CORRECTION TO THE "USE BEFORE" DATE.