PMA P960013S007

Device
TENDRIL SDX
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S007
Product code
DTB
Decision date
2000-03-07
Generic name
permanent pacemaker Electrode
Approval order statement
Approval for the Tendril SDX Model 1488/K/TC endocardial, steroid-eluting, active-fixation pacing leads.

Current openFDA PMA Record#

Device
TENDRIL SDX
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S007
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2000-03-07
Decision code
APPR
Date received
1999-09-13
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Tendril SDX Model 1488/K/TC endocardial, steroid-eluting, active-fixation pacing leads.