PMA P030036S156

Device
SelectSecure Lead
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P030036
Supplement
S156
Product code
NVN
Decision date
2026-02-10
Classification
Cardiovascular
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
a new vapor degreasing solvent

Current openFDA PMA Record#

Device
SelectSecure Lead
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P030036
Supplement
S156
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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