PMA P930039S211

Device
CapSureFix Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S211
Product code
NVN
Decision date
2020-06-02
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Approval for a change to the lead serial number ink/foil material for select implantable leads.

Current openFDA PMA Record#

Device
CapSureFix Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S211
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2020-06-02
Decision code
APPR
Date received
2020-03-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the lead serial number ink/foil material for select implantable leads.