PMA P950024S092

Device
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S092
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
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S092
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.