PMA P120017S010

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S010
Product code
DTB
Decision date
2017-08-16
Classification
Permanent Pacemaker Electrode
Generic name
permanent pacemaker Electrode
Approval order statement
Transfer of the incoming inspection activities for select components.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S010
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2017-08-16
Decision code
OK30
Date received
2017-08-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer of the incoming inspection activities for select components.