FDA.reportPublic FDA data

PMA P060039S113

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S113
Product code
OJX
Decision date
2023-02-06
Classification
Cardiovascular
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
Updates to the material supplier and associated component specification and BOM of the guidewire clip accessory used to prevent unwanted dislocation of the guidewire during implantation.

Current openFDA PMA Record#

Device
Attain StarFix Lead
Applicant
Medtronic, Inc.
PMA number
P060039
Supplement
S113
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date
2023-02-06
Decision code
OK30
Date received
2023-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the material supplier and associated component specification and BOM of the guidewire clip accessory used to prevent unwanted dislocation of the guidewire during implantation.