PMA P120017S023

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S023
Product code
DTB
Decision date
2020-08-06
Generic name
permanent pacemaker Electrode
Approval order statement
Transfer and expand inspection activities at the MPROC Juncos Facility.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S023
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2020-08-06
Decision code
OK30
Date received
2020-07-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer and expand inspection activities at the MPROC Juncos Facility.