PMA P120017S031

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S031
Product code
DTB
Decision date
2022-06-01
Generic name
permanent pacemaker Electrode
Approval order statement
Update the FACTORYWorks Manufacturing Execution System to Release 9.10.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S031
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2022-06-01
Decision code
OK30
Date received
2022-05-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the FACTORYWorks Manufacturing Execution System to Release 9.10.