PMA P950001S007

Device
ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
Applicant
Boston Scientific
PMA number
P950001
Supplement
S007
Product code
DTB
Decision date
2000-06-29
Generic name
permanent pacemaker Electrode
Approval order statement
APPROVAL FOR CHANGES TO THE LEAD STABILIZER COMPONENT.

Current openFDA PMA Record#

Device
ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
Applicant
Boston Scientific
PMA number
P950001
Supplement
S007
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2000-06-29
Decision code
APPR
Date received
2000-05-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR CHANGES TO THE LEAD STABILIZER COMPONENT.