PMA P060039S119

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S119
Product code
OJX
Decision date
2026-02-10
Classification
Cardiovascular
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
a new vapor degreasing solvent

Current openFDA PMA Record#

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S119
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date
2026-02-10
Decision code
OK30
Date received
2026-01-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new vapor degreasing solvent