PMA P120017S034

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S034
Product code
DTB
Decision date
2023-11-03
Classification
Cardiovascular
Generic name
permanent pacemaker Electrode
Approval order statement
approval to relocate the repackaging process to a new building

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S034
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2023-11-03
Decision code
OK30
Date received
2023-10-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval to relocate the repackaging process to a new building