PMA P120017S021

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S021
Product code
DTB
Decision date
2020-06-02
Generic name
permanent pacemaker Electrode
Approval order statement
Approval for a change to the lead serial number ink/foil material for select implantable leads.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S021
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2020-06-02
Decision code
APPR
Date received
2020-03-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the lead serial number ink/foil material for select implantable leads.