PMA P120017S039

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S039
Product code
DTB
Decision date
2026-02-20
Classification
Cardiovascular
Generic name
permanent pacemaker Electrode
Approval order statement
an update to the part cleaning process at supplier

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S039
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2026-02-20
Decision code
OK30
Date received
2026-01-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an update to the part cleaning process at supplier