PMA P980023S012

Device
KENTROX RV-S/KENTROX SL-S ICD LEADS
Applicant
Biotronik, Inc.
PMA number
P980023
Supplement
S012
Product code
DTA
Decision date
2003-11-18
Classification
Tester, Pacemaker Electrode Function
Generic name
TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement
APPROVAL FOR THE KENTROX RV-S AND KENTROX SL-S LEADS.

Current openFDA PMA Record#

Device
KENTROX RV-S/KENTROX SL-S ICD LEADS
Applicant
Biotronik, Inc.
PMA number
P980023
Supplement
S012
Product code
DTA
Generic name
TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date
2003-11-18
Decision code
APPR
Date received
2003-01-27
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE KENTROX RV-S AND KENTROX SL-S LEADS.