PMA P120017S028

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S028
Product code
DTB
Decision date
2021-08-17
Generic name
permanent pacemaker Electrode
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S028
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2021-08-17
Decision code
OK30
Date received
2021-08-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.