PMA P930039S229

Device
CapSureFix Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S229
Product code
NVN
Decision date
2021-08-17
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.

Current openFDA PMA Record#

Device
CapSureFix Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S229
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2021-08-17
Decision code
OK30
Date received
2021-08-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.