PMA P060039S111

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S111
Product code
OJX
Decision date
2022-06-01
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
Update the FACTORYWorks Manufacturing Execution System to Release 9.10.

Current openFDA PMA Record#

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S111
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) 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.