PMA P930039S224

Device
CapSureFix Novus Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S224
Product code
NVN
Decision date
2021-03-29
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Relocate the final packaging operations and select processing and equipment.

Current openFDA PMA Record#

Device
CapSureFix Novus Lead
Applicant
Medtronic, Inc.
PMA number
P930039
Supplement
S224
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2021-03-29
Decision code
OK30
Date received
2021-03-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocate the final packaging operations and select processing and equipment.