PMA P120017S027

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S027
Product code
DTB
Decision date
2021-03-04
Generic name
permanent pacemaker Electrode
Approval order statement
Process change relating to raw material at a supplier.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S027
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2021-03-04
Decision code
OK30
Date received
2021-02-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Process change relating to raw material at a supplier.